Cervical Priming Before Dilation & Evacuation

Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Abortion, Induced
• Intervention / Treatment: Drug: Misoprostol; Device: Laminaria

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7505
    • Tygerberg hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol	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
Experimental: Laminaria	Device: Laminaria; Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of women with fetal expulsion prior to dilation and evacuation	Prior to D&E procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
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)

Collaborators and Investigators

• Sponsor: Ibis Reproductive Health
• Collaborators: Society of Family Planning; University of Cape Town; Tygerberg Hospital; Safe Abortion Action Fund of the International Planned Parenthood Federation
• Investigators: Principal Investigator: Judy Kluge, MBChB, Tygerberg hospital

Publications and helpful links

General Publications

• Constant D, Kluge J, Harries J, Grossman D. An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa. Contraception. 2019 Sep;100(3):209-213. doi: 10.1016/j.contraception.2019.04.009. Epub 2019 Apr 25.
• Grossman D, Constant D, Lince-Deroche N, Harries J, Kluge J. A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa. Contraception. 2014 Sep;90(3):234-41. doi: 10.1016/j.contraception.2014.05.003. Epub 2014 May 14.

Helpful Links

• Click here to visit the Ibis Reproductive Health website

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (Estimate): May 14, 2012

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Misoprostol; Abortion, Induced; Laminaria; Pregnancy Trimester, Second
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 32020