Cervical Priming Before Dilation & Evacuation

Ibis Reproductive Health159 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

159

Conditions

Abortion, Induced

Interventions

MisoprostolDRUG

Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed

LaminariaDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tygerberg Hospital

Cape Town, South Africa

Outcomes

Primary Outcomes

Proportion of women with fetal expulsion prior to dilation and evacuation

Time frame: Prior to D&E procedure

Secondary Outcomes

Proportion of women requiring additional dilation (manual or pharmacologic)

Time frame: At time of D&E procedure

Duration of dilation and evacuation procedure

Time frame: End of D&E procedure

Frequency of major complications

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

Time frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)

Frequency of Minor Complications

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

Time frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)

Data from ClinicalTrials.gov

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