Cervical Priming Before Dilation & Evacuation

Abortion, Induced Clinical Trial

Official title:

Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597726
• Other study ID #: 32020
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: November 6, 2013
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Ibis Reproductive Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

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

Locations

Country	Name	City	State
South Africa	Tygerberg Hospital	Cape Town

Sponsors (5)

Lead Sponsor	Collaborator
Ibis Reproductive Health	Safe Abortion Action Fund of the International Planned Parenthood Federation, Society of Family Planning, Tygerberg Hospital, University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women with fetal expulsion prior to dilation and evacuation		Prior to D&E procedure	Yes
Secondary	Proportion of women requiring additional dilation (manual or pharmacologic)		At time of D&E procedure	No
Secondary	Duration of dilation and evacuation procedure		End of D&E procedure	No
Secondary	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	Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)	Yes
Secondary	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	Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)	Yes

External Links

•   Click here to visit the Ibis Reproductive Health website