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

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.