Cervical Priming Before Dilation & Evacuation

Ibis Reproductive Health

Status: Completed

Conditions: Abortion, Induced

Treatments: Device: Laminaria; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01597726

32020

Details and patient eligibility

About

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

Full 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

Enrollment: 159 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 2 patient groups

Misoprostol

Active Comparator group

Treatment:

Drug: Misoprostol

Laminaria

Experimental group

Treatment:

Device: Laminaria