Introduction of a single visit protocol in the management of selected patients with pregnancy of unknown location: a prospective study

Abstract

Objective: To prospectively evaluate the efficacy and safety of a modified clinical protocol using serum progesterone for the management of women with a pregnancy of unknown location (PUL).

Design: Prospective interventional study.

Population: Women with a pregnancy of unknown location and low serum progesterone level.

Methods: A management protocol was introduced into clinical practice whereby clinically stable patients with PUL and serum progesterone level ≤ 10 nmol/l were discharged after their initial visit. Patients were advised to contact or attend the early pregnancy unit if they developed abdominal pain or heavy vaginal bleeding.

Main outcome measures: Need for repeat visits or intervention following discharge.

Results: In total, 6201 pregnant women were seen during the study period. Of those, 676 (10.9%; 95% CI 10.1-11.7%) had an ultrasound diagnosis of PUL, and 252 of the 676 (37%; 95% CI 33.4-40.9%) had progesterone levels ≤ 10 nmol/l, and were followed-up by telephone 4 weeks later or by faxing the GP at an interval if the patient failed to respond. Follow-up was completed in 227 of the 252 women (90.1%). In 212 of the 227 women (93.4%; 95% CI 90.68-96.1%) the pregnancy resolved without any complications, whereas 15 women (6.6%; 95% CI, 3.9-9.32%) re-attended because of persistent or worsening symptoms. Only four of the 227 women (1.7%; 95% CI, 0.3-3.2%) required surgical intervention. None of these experienced any significant complications.

Conclusions: A clinical protocol based on serum progesterone measurements is effective for triaging and managing women with PULs. Implementation of the single-visit protocol into routine practice reduces the need for follow-up of these women without compromising their safety.