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Meta-Analysis
. 2016 May 11;2016(5):CD010607.
doi: 10.1002/14651858.CD010607.pub2.

Interventions for treating hyperemesis gravidarum

Rupsa C Boelig  1 , Samantha J Barton, Gabriele Saccone, Anthony J Kelly, Steve J Edwards, Vincenzo Berghella
Affiliations
Meta-Analysis

Interventions for treating hyperemesis gravidarum

Rupsa C Boelig et al. Cochrane Database Syst Rev. .

Abstract

Background: Hyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for hospitalization during pregnancy. While a previous Cochrane review examined interventions for nausea and vomiting in pregnancy, there has not yet been a review examining the interventions for the more severe condition of hyperemesis gravidarum.

Objectives: To assess the effectiveness and safety, of all interventions for hyperemesis gravidarum in pregnancy up to 20 weeks' gestation.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register and the Cochrane Complementary Medicine Field's Trials Register (20 December 2015) and reference lists of retrieved studies.

Selection criteria: Randomized controlled trials of any intervention for hyperemesis gravidarum. Quasi-randomized trials and trials using a cross-over design were not eligible for inclusion.We excluded trials on nausea and vomiting of pregnancy that were not specifically studying the more severe condition of hyperemesis gravidarum.

Data collection and analysis: Two review authors independently reviewed the eligibility of trials, extracted data and evaluated the risk of bias. Data were checked for accuracy.

Main results: Twenty-five trials (involving 2052 women) met the inclusion criteria but the majority of 18 different comparisons described in the review include data from single studies with small numbers of participants. The comparisons covered a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various pharmaceutical interventions. The methodological quality of included studies was mixed. For selected important comparisons and outcomes, we graded the quality of the evidence and created 'Summary of findings' tables. For most outcomes the evidence was graded as low or very low quality mainly due to the imprecision of effect estimates. Comparisons included in the 'Summary of findings' tables are described below, the remaining comparisons are described in detail in the main text.No primary outcome data were available when acupuncture was compared with placebo, There was no clear evidence of differences between groups for anxiodepressive symptoms (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.40; one study, 36 women, very low-quality evidence), spontaneous abortion (RR 0.48, 95% CI 0.05 to 5.03; one study, 57 women, low-quality evidence), preterm birth (RR 0.12, 95% CI 0.01 to 2.26; one study, 36 women, low-quality evidence), or perinatal death (RR 0.57, 95% CI 0.04 to 8.30; one study, 36 women, low-quality evidence).There was insufficient evidence to identify clear differences between acupuncture and metoclopramide in a study with 81 participants regarding reduction/cessation in nausea or vomiting (RR 1.40, 95% CI 0.79 to 2.49 and RR 1.51, 95% CI 0.92 to 2.48, respectively; very low-quality evidence).In a study with 92 participants, women taking vitamin B6 had a slightly longer hospital stay compared with placebo (mean difference (MD) 0.80 days, 95% CI 0.08 to 1.52, moderate-quality evidence). There was insufficient evidence to demonstrate a difference in other outcomes including mean number of episodes of emesis (MD 0.50, 95% CI -0.40 to 1.40, low-quality evidence) or side effects.A comparison between metoclopramide and ondansetron identified no clear difference in the severity of nausea or vomiting (MD 1.70, 95% CI -0.15 to 3.55, and MD -0.10, 95% CI -1.63 to 1.43; one study, 83 women, respectively, very low-quality evidence). However, more women taking metoclopramide complained of drowsiness and dry mouth (RR 2.40, 95% CI 1.23 to 4.69, and RR 2.38, 95% CI 1.10 to 5.11, respectively; moderate-quality evidence). There were no clear differences between groups for other side effects.In a single study with 146 participants comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness, dizziness, and dystonia (RR 0.70, 95% CI 0.56 to 0.87, RR 0.48, 95% CI 0.34 to 0.69, and RR 0.31, 95% CI 0.11 to 0.90, respectively, moderate-quality evidence). There were no clear differences between groups for other important outcomes including quality of life and other side effects.In a single trial with 30 women, those receiving ondansetron had no difference in duration of hospital admission compared to those receiving promethazine (MD 0.00, 95% CI -1.39 to 1.39, very low-quality evidence), although there was increased sedation with promethazine (RR 0.06, 95% CI 0.00 to 0.94, low-quality evidence) .Regarding corticosteroids, in a study with 110 participants there was no difference in days of hospital admission compared to placebo (MD -0.30, 95% CI -0.70 to 0.10; very low-quality evidence), but there was a decreased readmission rate (RR 0.69, 95% CI 0.50 to 0.94; four studies, 269 women). For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, there was insufficient evidence to identify differences between groups (very low-quality evidence for all outcomes). In other single studies there were no clear differences between groups for preterm birth or side effects (very low-quality evidence).For hydrocortisone compared with metoclopramide, no data were available for primary outcomes and there was no difference in the readmission rate (RR 0.08, 95% CI 0.00 to 1.28;one study, 40 women).In a study with 80 women, compared to promethazine, those receiving prednisolone had increased nausea at 48 hours (RR 2.00, 95% CI 1.08 to 3.72; low-quality evidence), but not at 17 days (RR 0.81, 95% CI 0.58 to 1.15, very low-quality evidence). There was no clear difference in the number of episodes of emesis or subjective improvement in nausea/vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth.

Authors' conclusions: On the basis of this review, there is little high-quality and consistent evidence supporting any one intervention, which should be taken into account when making management decisions. There was also very limited reporting on the economic impact of hyperemesis gravidarum and the impact that interventions may have.The limitations in interpreting the results of the included studies highlights the importance of consistency in the definition of hyperemesis gravidarum, the use of validated outcome measures, and the need for larger placebo-controlled trials.

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Conflict of interest statement

Rupsa C Boelig: none known.

Samantha J Barton: none known.

Gabriele Saccone: none known.

Anthony J Kelly:none known.

Steve J Edwards: none known.

Vincenzo Berghella:none known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 1 Number of women requiring additional antiemetics.
1.2
1.2. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 2 Spontaneous abortion.
1.3
1.3. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 3 Preterm birth less than 37 weeks.
1.4
1.4. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 4 Stillbirth and neonatal death.
1.5
1.5. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 5 Decision to terminate the pregnancy.
1.6
1.6. Analysis
Comparison 1 Acupuncture and acupressure vs placebo, Outcome 6 Quality of life: anxiodepressive symptomatology.
2.1
2.1. Analysis
Comparison 2 Acupuncture vs metoclopramide, Outcome 1 Reduction or cessation in nausea.
2.2
2.2. Analysis
Comparison 2 Acupuncture vs metoclopramide, Outcome 2 Reduction or cessation in vomiting.
3.1
3.1. Analysis
Comparison 3 Acupunture vs Western medicine (Phenobarbital), Outcome 1 Complete recovery.
3.2
3.2. Analysis
Comparison 3 Acupunture vs Western medicine (Phenobarbital), Outcome 2 Obvious effects.
3.3
3.3. Analysis
Comparison 3 Acupunture vs Western medicine (Phenobarbital), Outcome 3 Effects showed.
3.4
3.4. Analysis
Comparison 3 Acupunture vs Western medicine (Phenobarbital), Outcome 4 Ineffective.
3.5
3.5. Analysis
Comparison 3 Acupunture vs Western medicine (Phenobarbital), Outcome 5 Total effective rate.
4.1
4.1. Analysis
Comparison 4 Acupunture vs Chinese medicine, Outcome 1 Complete recovery.
4.2
4.2. Analysis
Comparison 4 Acupunture vs Chinese medicine, Outcome 2 Obvious effects.
4.3
4.3. Analysis
Comparison 4 Acupunture vs Chinese medicine, Outcome 3 Effects showed.
4.4
4.4. Analysis
Comparison 4 Acupunture vs Chinese medicine, Outcome 4 Ineffective.
4.5
4.5. Analysis
Comparison 4 Acupunture vs Chinese medicine, Outcome 5 Total effective rate.
5.1
5.1. Analysis
Comparison 5 Chinese medicine vs Western medicine (Phenobarbital), Outcome 1 Complete recovery.
5.2
5.2. Analysis
Comparison 5 Chinese medicine vs Western medicine (Phenobarbital), Outcome 2 Obvious effects.
5.3
5.3. Analysis
Comparison 5 Chinese medicine vs Western medicine (Phenobarbital), Outcome 3 Effects showed.
5.4
5.4. Analysis
Comparison 5 Chinese medicine vs Western medicine (Phenobarbital), Outcome 4 Ineffective.
5.5
5.5. Analysis
Comparison 5 Chinese medicine vs Western medicine (Phenobarbital), Outcome 5 Total effective rate.
6.1
6.1. Analysis
Comparison 6 Muscle relaxation and pharmacotherapy vs only pharmacotherapy alone, Outcome 1 Clinical Global Improvement score.
7.1
7.1. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 1 PUQE.
7.2
7.2. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 2 Hours of hospital admission.
7.3
7.3. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 3 Decision to terminate the pregnancy.
7.4
7.4. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 4 Spontaneous miscarriage.
7.5
7.5. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 5 Small for gestational age.
7.6
7.6. Analysis
Comparison 7 Midwife‐led outpatient care vs routine care, Outcome 6 Economic cost.
8.1
8.1. Analysis
Comparison 8 Holistic assessment with standard care vs standard care, Outcome 1 PUQE.
8.2
8.2. Analysis
Comparison 8 Holistic assessment with standard care vs standard care, Outcome 2 Quality of life: social functioning.
8.3
8.3. Analysis
Comparison 8 Holistic assessment with standard care vs standard care, Outcome 3 Quality of life: client satisfaction.
9.1
9.1. Analysis
Comparison 9 Dextrose saline vs normal saline rehydration, Outcome 1 Hours of hospital admission.
10.1
10.1. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 1 Number of episodes of emesis.
10.2
10.2. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 2 Days of hospital admission.
10.3
10.3. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 3 Hospital readmission.
10.4
10.4. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 4 Weight change (kg).
10.5
10.5. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 5 Interventions side effects: dizziness.
10.6
10.6. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 6 Interventions side effects: headaches.
10.7
10.7. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 7 Interventions side effects: diarrhea.
10.8
10.8. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 8 Interventions side effects: palpitations.
10.9
10.9. Analysis
Comparison 10 Pyridoxine vs placebo, Outcome 9 Interventions side effects: dry mouth.
11.1
11.1. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 1 Severity of nausea.
11.2
11.2. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 2 Severity of vomiting.
11.3
11.3. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 3 Intervention side effects: felt drowsy.
11.4
11.4. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 4 Intervention side effects: dry mouth.
11.5
11.5. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 5 Intervention side effects: unable to sleep.
11.6
11.6. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 6 Intervention side effects: felt dizzy.
11.7
11.7. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 7 Intervention side effects: diarrhea.
11.8
11.8. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 8 Intervention side effects: headache.
11.9
11.9. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 9 Intervention side effects: palpitations.
11.10
11.10. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 10 Intervention side effects: skin rash.
11.11
11.11. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 11 Intervention side effects: dystonia.
11.12
11.12. Analysis
Comparison 11 Metoclopramide vs ondansetron, Outcome 12 Quality of life.
12.1
12.1. Analysis
Comparison 12 Hydrocortisone vs metoclopramide, Outcome 1 Hospital readmission.
12.2
12.2. Analysis
Comparison 12 Hydrocortisone vs metoclopramide, Outcome 2 Need for enteral or parenteral nutrition.
13.1
13.1. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 1 Quality of life.
13.2
13.2. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 2 Intervention side effects: unable to sleep.
13.3
13.3. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 3 Intervention side effects: dry mouth.
13.4
13.4. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 4 Intervention side effects: diarrhea.
13.5
13.5. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 5 Intervention side effects: headache.
13.6
13.6. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 6 Intervention side effects: palpitations.
13.7
13.7. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 7 Intervention side effects: skin rash.
13.8
13.8. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 8 Intervention side effects: drowsy.
13.9
13.9. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 9 Intervention side effects: felt dizzy.
13.10
13.10. Analysis
Comparison 13 Metoclopramide vs promethazine, Outcome 10 Intervention side effects: dystonia.
14.1
14.1. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 1 Days of hospital admission.
14.2
14.2. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 2 Hospital readmission.
14.3
14.3. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 3 Women requiring additional antiemetics.
14.4
14.4. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 4 Congenital anomalies.
14.5
14.5. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 5 Preterm birth.
14.6
14.6. Analysis
Comparison 14 Parenteral fluid with diazepam vs parenteral fluid without diazepam, Outcome 6 Decision to terminate the pregnancy.
15.1
15.1. Analysis
Comparison 15 Ondansetron vs promethazine, Outcome 1 Days of hospital admission.
15.2
15.2. Analysis
Comparison 15 Ondansetron vs promethazine, Outcome 2 Intervention side effect: sedation.
16.1
16.1. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 1 Severe nausea 48 hours.
16.2
16.2. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 2 Severe nausea 17th day.
16.3
16.3. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 3 Episodes of vomiting 48 hours.
16.4
16.4. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 4 Episodes of vomiting 17th day.
16.5
16.5. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 5 Therapy failure in 2 days.
16.6
16.6. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 6 Hospital readmission.
16.7
16.7. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 7 Number of women requiring additional antiemetics.
16.8
16.8. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 8 Stillbirth and neonatal death.
16.9
16.9. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 9 Preterm birth.
16.10
16.10. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 10 Decision to terminate the pregnancy.
16.11
16.11. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 11 Intevention side effects: abdominal pain 48 hours.
16.12
16.12. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 12 Intervention side effects: abdominal pain 3‐10 days.
16.13
16.13. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 13 Intervention side effects: drowsiness 48 hours and 3‐10 days.
16.14
16.14. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 14 Became completely or partially well 48 hours.
16.15
16.15. Analysis
Comparison 16 Corticosteroids vs promethazine, Outcome 15 Became completely or partially well 17th day.
17.1
17.1. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 1 Days of hospital admission.
17.2
17.2. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 2 Hospital readmission.
17.3
17.3. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 3 Pregnancy complications.
17.4
17.4. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 4 Spontaneous abortion.
17.5
17.5. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 5 Stillbirth and neonatal death.
17.6
17.6. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 6 Congenital abnormalities.
17.7
17.7. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 7 Low birthweight.
17.8
17.8. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 8 Small‐for‐gestational age.
17.9
17.9. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 9 Preterm birth.
17.10
17.10. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 10 Intervention side effects.
17.11
17.11. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 11 Women requiring additional antiemetic drugs.
17.12
17.12. Analysis
Comparison 17 Corticosteroids vs placebo, Outcome 12 Decision to terminate the pregnancy.
18.1
18.1. Analysis
Comparison 18 ACTH vs placebo, Outcome 1 Reduction or cessation in nausea/vomiting.
18.2
18.2. Analysis
Comparison 18 ACTH vs placebo, Outcome 2 Weight gain (kg).
18.3
18.3. Analysis
Comparison 18 ACTH vs placebo, Outcome 3 Hospital readmission.
18.4
18.4. Analysis
Comparison 18 ACTH vs placebo, Outcome 4 Spontaneous abortion.
18.5
18.5. Analysis
Comparison 18 ACTH vs placebo, Outcome 5 Preterm birth.
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References

References to studies included in this review

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Ziaei 2004 {published data only}
    1. Ziaei S, Hosseiney FS, Faghihzadeh S. The efficacy low dose of prednisolone in the treatment of hyperemesis gravidarum. Acta Obstetricia et Gynecologica Scandinavica 2004;83:272‐5. - PubMed

References to studies excluded from this review

Adamczak 2007 {published data only}
    1. Adamczak J, Kasdaglis J, Rinehart B, Antebi Y, Wolf E, Terrone D. A prospective randomized trial of solumedrol dose pack vs. phenergan for the treatment of symptomatic nausea and vomiting in pregnancy. American Journal of Obstetrics and Gynecology 2007;197(6 Suppl 1):S88, Abstract no: 277.
Carlsson 2000 {published data only}
    1. Carlsson CP, Axemo P, Bodin A, Carstensen H, Ehrenroth B, Madegard‐Lind I, et al. Manual acupuncture reduces hyperemesis gravidarum: a placebo‐controlled, randomized, single‐blind, crossover study. Journal of Pain & Symptom Management 2000;20(4):273‐9. - PubMed
Dehkordi 2013 {published data only}
    1. Dehkordi EJ. Comparison of "Cydonia Oblonga" fruit product with B6 on nausea and vomiting in pregnancy. IRCT: Iranian Register of Clinical Trials 2013.
Erez 1971 {published data only}
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Ferruti 1982 {published data only}
    1. Ferruti MM, Speranza R. Use of the combination of adrenal cortex extract, pyridoxal‐5‐phosphate, cyanocobalamin and ascorbic acid in the treatment of hypocorticism in pregnancy [Italian] [Sulla utilita dell'associazione di estratto corticosurrenale, piridossal‐5‐fosfato, cianocobalamina e acido ascorbico nel trattamento degli stati di ipocorticalismo in gravidanza.]. Minerva Ginecologica 1982;34:619‐23. - PubMed
Fischer‐Rasmussen 1991 {published data only}
    1. Fischer‐Rasmussen W, Kjaer SK, Dahl C, Asping U. Ginger treatment of hyperemesis gravidarum. European Journal of Obstetrics & Gynecology and Reproductive Biology 1991;38(1):19‐24. - PubMed
Ghahiri 2011 {published data only}
    1. Ghahiri AA, Abdi F, Mastoo R, Ghasemi M. The effect of ondansetron and metoclopramide in nausea and vomiting of pregnancy. Journal of Isfahan Medical School 2011; Vol. 29, issue 131.
Gordon 2013 {published data only}
    1. Gordon GH. Dextrose saline compared with normal saline rehydration of hyperemesis gravidarum: a randomized controlled trial. Obstetrics and Gynecology 2013;121(6):1360. - PubMed
Kadan 2009 {published data only}
    1. Kadan Y. Does thiamine help vomiting and nausea in pregnancy?. ClinicalTrials.gov (http://clinicaltrials.gov) (accessed 31 July 2009) 2009.
Koren 2006 {published data only}
    1. Koren G. Pre‐emptive treatment of severe nausea and vomiting of pregnancy (ongoing trial). ClinicalTrials.gov (http://clinicaltrials.gov/) (accessed 21 March 2006) 2006.
Koren 2010 {published data only}
    1. Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, et al. Effectiveness of delayed‐release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. American Journal of Obstetrics and Gynecology 2010;203(6):571.e1‐7. - PubMed
Koren 2013 {published data only}
    1. Koren G, Maltepe C. Preemptive Diclectin therapy for the management of nausea and vomiting of pregnancy and hyperemesis gravidarum. American Journal of Obstetrics and Gynecology 2013;208(1 Suppl):S20.
Koren 2015 {published data only}
    1. Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, et al. Maternal safety of the delayed‐release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy and Childbirth 2015;15(1):488. - PMC - PubMed
Lask 1953 {published data only}
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Ling 1994 {published data only}
    1. Ling KM, Dalton M. Progesterone and hyperemesis. British Journal of Family Planning 1994;19(Suppl):9‐10.
Liu 1994 {published data only}
    1. Liu RF, Chen XQ. Treatment of severe pregnant vomiting with mainly self‐made Zengye Ding'ou Tang in 68 cases. Chinese Journal of Integrated Traditional and Western Medicine 1994;14(11):692‐3.
Madegard‐Linh 2004 {published data only}
    1. Madegard‐Linh I. Manual acupuncture reduces hyperemesis gravidarum: a placebo‐controlled, randomized, single‐blind, crossover study. 10th International Conference of Maternity Care Researchers; 2004 June 13‐16; Lund, Sweden. 2004. - PubMed
Magee 1996 {published data only}
    1. Magee LA, Redman CW. An N‐of‐1 trial for treatment of hyperemesis gravidarum. British Journal of Obstetrics and Gynaecology 1996;103(5):478‐80. - PubMed
Maina 2012 {published data only}
    1. Maina A. Transdermal clonidine in the treatment of severe hyperemesis gravidarum (clonemesi). ClinicalTrials.gov (http://clinicaltrials.gov/) [accessed 21 May 2013] 2012.
Maina 2014 {published data only}
    1. Maina A, Arrotta M, Cicogna L, Donvito V, Mischinelli M, Todros T, et al. Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI. BJOG: an International Journal of Obstetrics and Gynaecology 2014;121(12):1556‐63. - PubMed
Maltepe 2012 {published data only}
    1. Maltepe C, Koren G. Pre‐emptive diclectin treatment for nausea and vomiting of pregnancy: Results of a randomized controlled trial. Birth Defects Research Part A ‐ Clinical and Molecular Teratology 2012;94(5):327.
Matok 2013 {published data only}
    1. Matok I, Umans J, Feghali MN, Clark S, Caritis S, Miodovnik M, et al. Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial. Journal of Obstetrics & Gynaecology 2013;33(6):557‐60. - PubMed
Matok 2014 {published data only}
    1. Matok I, Clark S, Caritis S, Miodovnik M, Umans G, Hankins G, et al. Studying the antiemetic effect of vitamin B6 for morning sickness: Pyridoxine and pyridoxal are prodrugs. Journal of Clinical Pharmacology 2014;54(12):1429‐33. - PubMed
McCarthy 2014b {published data only}
    1. Higgins JR. Day care versus inpatient management of nausea and vomiting of pregnancy ‐ D.I.M. trial. Current Controlled Trials (http://controlled‐trials.com/) (accessed 5 January 2009) 2009.
    1. Higgins JR. Randomized controlled trial of day care versus inpatient management of nausea and vomiting of pregnancy. ClinicalTrials.gov (http://clinicaltrials.gov/) (accessed 21 May 2013) 2008.
    1. McCarthy FP, Murphy A, Khashan AS, McElroy B, Spillane N, Marchocki Z, et al. Day care compared with inpatient management of nausea and vomiting of pregnancy: a randomized controlled trial. Obstetrics & Gynecology 2014;124(4):743‐8. - PubMed
Nguyen 2008 {published data only}
    1. Nguyen H. The efficacy of diclectin for nausea and vomiting of pregnancy. ClinicalTrials.gov (http://clinicaltrials.gov/) (accessed 20 February 2008) 2008.
Oliveira 2014 {published data only}
    1. Capp S, Oliveira L, Carstairs S, You W. Ondansetron versus doxylamine/pyridoxine for treatment of nausea and vomiting in pregnancy: a prospective randomized double‐blind trial. American Journal of Obstetrics and Gynecology 2014;210(1 Suppl):S39.
    1. Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with Doxylamine and Pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstetrics and Gynecology 2014;124(4):735‐42. - PubMed
Ozgoli 2009 {published data only}
    1. Ozgoli G, Goli M, Simbar M. Effects of ginger capsules on pregnancy, nausea, and vomiting. Journal of Alternative and Complementary Medicine 2009;15(3):243‐6. - PubMed
Ozgoli 2011 {published data only}
    1. Ozgoli G. Study of Cardamom powder effect on the severity of nausea and vomiting in pregnant women referred to health centers in Chalus city 1389‐90. IRCT Iranian Registry of Clinical Trials (www.irct.ir) [accessed 1 March 2014] 2011.
Price 1964 {published data only}
    1. Price JJ, Barry MC. A double blind study of fluphenazine with pyridoxine. Pennsylvania Medical Journal 1964;67:37‐40. - PubMed
Rad 2010 {published data only}
    1. Rad MN. Evaluation of the influence of KID 21 (youmen) point acupressure on nausea and vomiting of pregnancy. IRCT Iranian Registry of Clinical Trials (www.irct.ir) [accessed 6 December 2010] 2010.
Rosen 2003 {published data only}
    1. Rosen T, Veciana M, Miller HS, Stewart L, Rebarber A, Slotnick RN. A randomized controlled trial of nerve stimulation for relief of nausea and vomiting in pregnancy. Obstetrics & Gynecology 2003;102(1):129‐35. - PubMed
Shin 2005 {published data only}
    1. Shin HS, Song YA. The effect of P6 acupressure for symptom control in pregnant women having hyperemesis gravidarum. Journal of Korean Academy of Nursing 2005;35(3):593‐601. - PubMed
Weiner 1990 {published data only}
    1. Weiner CP. Trial to evaluate the efficacy of promethazine vs metoclopramine in the treatment of hyperemesis gravidarum. Personal communication 1990.
Wibowo 2012 {published data only}
    1. Wibowo N, Purwosunu Y, Sekizawa A, Farina A, Tambunan V, Bardosono S. Vitamin B(6) supplementation in pregnant women with nausea and vomiting. International Journal of Gynecology and Obstetrics 2012;116(3):206‐10. - PubMed
Willetts 2003 {published data only}
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References to studies awaiting assessment

Eftekhari 2013 {published data only}
    1. Eftekhari N, Mehralhasani Y. A comparison of ondansetron and promethasin in treating hyperemesis gravidarum. Journal of Kerman University of Medical Sciences 2013;20(4):354‐65.
He 2009 {published data only}
    1. He XL, Zhong G, He Y. Clinical observation on treatment of hyperemesis gravidarum by integrative Chinese and Western medicine and its influence on serum motilin. Chinese Journal of Integrated Traditional and Western Medicine 2009;29(10):872‐4. - PubMed

References to ongoing studies

Cyna 2008 {published data only}
    1. Cyna A. The effects of antenatal hypnosis on suffering associated with hyperemesis in early pregnancy. Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) (accessed 19 February 2008) 2008.
Guttuso 2014 {published data only}
    1. Guttuso T. Comparison of gabapentin and metoclopramide for treating hyperemesis gravidarum. ClinicalTrials.gov (http://clinicaltrials.gov) [accessed 28 October 2015] 2014.
Koren 2014 {published data only}
    1. Koren G, Hankins G. A multicenter trial of the efficacy and safety of Diclegis® for nausea and vomiting of pregnancy in pregnant adolescents. ClinicalTrials.gov (http://clinicaltrials.gov/) [accessed 5 February 2014] 2014.
Mehrolhasani 2012 {published data only}
    1. Mehrolhasani Y. Comparison of Demitron and promethazin in treatment of hyperemesis gravidarum. Iranian Registry of Clinical Trials (accessed 22 July 2013) 2012.
Mitchell‐Jones 2014 {published data only}
    1. Mitchell‐Jones N. Hyperemesis In Pregnancy (HIP) Trial: Inpatient versus outpatient management of severe nausea and vomiting in pregnancy. ISRCTN Registry (http://www.isrctn.com/) [accessed 28 October 2015] 2014.

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