NCT01597726

Cervical Priming Before Dilation & Evacuation

Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Ibis Reproductive Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DRUG	Misoprostol	Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed
DEVICE	Laminaria	Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-05-14
• Last updated: 2013-11-07

Locations

1 site across 1 country: South Africa