Cervical Priming Before Dilation & Evacuation

Not Applicable

Completed

• Conditions: Abortion, Induced
• Interventions: Drug: Misoprostol; Device: Laminaria

• Registration Number: NCT01597726
• Lead Sponsor: Ibis Reproductive Health

Brief Summary

The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D\&E at 13-20 weeks gestation in the Western Cape Province, South Africa

Detailed Description

As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D\&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D\&E:

1. Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose (a modified version of the current protocol)

2. Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-14
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

Inclusion Criteria

• Woman seeking TOP between 13 and 20 weeks gestation as determined by ultrasound
• Age 18 or greater
• Willingness to participate in randomized study
• Fluency in English, Afrikaans or Xhosa
• Ability to give informed consent
• Staying within one hour travel time of Tygerberg Hospital for the night prior to the D&E
• Ability to be contacted by telephone

Exclusion Criteria

• Active cervicitis
• Multiple gestation
• Fetal demise confirmed by ultrasound examination
• History of bleeding disorder or current anticoagulation therapy
• Allergy to misoprostol
• Currently breastfeeding and unwilling or unable to temporarily discard milk
• More than one prior cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	-
Laminaria	Laminaria	-

Primary Outcome Measures

Name	Time	Method
Proportion of women with fetal expulsion prior to dilation and evacuation	Prior to D&E procedure

Secondary Outcome Measures

Name	Time	Method
Proportion of women requiring additional dilation (manual or pharmacologic)	At time of D&E procedure
Duration of dilation and evacuation procedure	End of D&E procedure
Frequency of major complications	Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)	Major complications to include: * Death; * Admission to the ward after the procedure; * Readmission after discharge; * Abdominal surgical procedure; * Suspected uterine perforation; * Seizure; * Hemorrhage requiring transfusion; * Loss to follow-up after placement of laminaria
Frequency of Minor Complications	Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)	Minor complications to include: * Hemorrhage not requiring transfusion; * Infection requiring outpatient treatment; * Trauma to cervix or vagina; * Transfer to another facility to complete the procedure; * Need for repeat surgical evacuation of the uterus

Trial Locations

Locations (1)

Tygerberg Hospital; 🇿🇦 Cape Town, South Africa