Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec 27;23(1):1053.
doi: 10.1186/s13063-022-07041-x.

Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth-a protocol for a randomized clinical trial

Thuany Bento Herculano  1 , Fernanda Garanhani Surita  2 , Cássia Raquel Teatin Juliato  2 , Patrícia Moretti Rehder  2
Affiliations

Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth-a protocol for a randomized clinical trial

Thuany Bento Herculano et al. Trials. .

Abstract

Background: Ensuring effective and long-term contraception in the immediate postpartum period is an effective strategy for reducing unplanned pregnancies. In the meantime, the intrauterine device (IUD) is an excellent option. The aim of our study was to evaluate the best way to insert post-placental IUDs in the immediate postpartum period. Discomfort during insertion, expulsion rate, uterine perforation rate, and proper positioning 40-60 days postpartum will be analyzed.

Methods: Randomized, controlled, open clinical trial. The study group will be composed of women between 18 and 43 years old who are admitted for vaginal birth at the Women's Hospital of the State University of Campinas and who wish to use the IUD as a contraceptive method. The sample will be randomized into two insertion groups: manual and forceps. To calculate the sample size, the method of comparing the proportion between 2 groups was used, setting the level of significance alpha at 5% (alpha=0.05) and the power of the sample at 80% (beta=0.20). Based on the results, it was estimated that a sample of n=186 women (n=93 with manual insertion and n=93 with forceps) would be representative for comparison of expulsion between the 2 groups. All participants will undergo a postpartum consultation 40-60 days after birth with transvaginal ultrasound to assess the proper placement of the IUD.

Discussion: Insertion of an IUD in the immediate postpartum period has been considered a good option to increase coverage and access to contraception, and its benefit outweighs the inconvenience of a higher expulsion rate.

Trial registration: This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 50497321.4.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC) (number RBR-4j62jv6). This is the first version of the study protocol approved on 11/12/2021 prior to the start of participant recruitment.

Keywords: Contraception; Intrauterine device (IUD); Postpartum period; Vaginal birth, Immediate post-placental insertion.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Modified Kelly forceps
Fig. 2
Fig. 2
Hand position for IUD protection during insertion
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Conde-Agudelo A, Rosas-Bermudez A, Castaño F, Norton MH. Effects of birth spacing on maternal, perinatal, infant, and child health: a systematic review of causal mechanisms. Stud Fam Plann. 2012;43:9. doi: 10.1111/j.1728-4465.2012.00308.x. - DOI - PubMed
    1. Conde-Agudelo A, Belizán JM, Lammers C. Maternal-perinatal morbidity and mortality associated with adolescent pregnancy in Latin America: cross-sectional study. Am J Obstet Gynecol. 2005;192:342–349. doi: 10.1016/j.ajog.2004.10.593. - DOI - PubMed
    1. DaVanzo J, Hale L, Razzaque A, Rahmand M. Effects of interpregnancy interval and outcome of the preceding pregnancy on pregnancy outcomes in MATLAB, Bangladesh. BJOG. 2007;114:1079–1087. doi: 10.1111/j.1471-0528.2007.01338.x. - DOI - PMC - PubMed
    1. Cleland J, Bernstein S, Ezeh A, Faundes A, Glasier A, Innis J. Family planning: the unfinished agenda. Lancet. 2006;368:1810–1827. doi: 10.1016/S0140-6736(06)69480-4. - DOI - PubMed
    1. Rossier C, Bradley SEK, Ross J, Winfrey W. Reassessing unmet need for family planning in the postpartum period. Stud Fam Plann. 2015;46(4):355–367. doi: 10.1111/j.1728-4465.2015.00037.x. - DOI - PubMed

Publication types

LinkOut - more resources