CompletedPhase 4

Uterotonic Prophylaxis Trial

United States284 participantsStarted 2015-03

Plain-language summary

Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 20 wks 0 days gestation and 24 wks 0 days gestation * English or Spanish speaking * BP before injection 140/90 or below * 18 years old or over Exclusion criteria: * hypertension either on the preoperative or operative day (defined as systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg) * D\&E procedures with more than one day of cervical preparation with dilators * use of protease inhibitors * known coagulopathy * known morbidly adherent placenta

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria

Timeframe: Approximately 1-2 hours after procedure

Amount of Post-procedure Blood Loss Measured in mL

Timeframe: measured 1 to 2 hours after procedure

Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge

Timeframe: duration of procedure and until discharged from hospital

Number of Participants Who Returned to OR for Re-aspiration During Recovery Period

Timeframe: from cervical preparation through discharge

Number of Participants Who Were Admitted for Bleeding After Procedure

Timeframe: post-procedure and during recovery until discharge

Number of Participants Given Any Uterotonic

Timeframe: intra-operative or post-operative until discharge

Trial details

NCT IDNCT02408965

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

Results submitted2018-05-09

View on ClinicalTrials.gov More Hemorrhage trials