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Cervical Priming Before Dilation & Evacuation

Primary Purpose

Abortion, Induced

Status

Completed

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Misoprostol

Laminaria

About this trial

This is an interventional treatment trial for Abortion, Induced focused on measuring Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Tygerberg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Misoprostol

Laminaria

Arm Description

Outcomes

Primary Outcome Measures

Proportion of women with fetal expulsion prior to dilation and evacuation

Secondary Outcome Measures

Proportion of women requiring additional dilation (manual or pharmacologic)

Duration of dilation and evacuation 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

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

Full Information

NCT ID

NCT01597726

First Posted

May 10, 2012

Last Updated

November 6, 2013

Sponsor

Ibis Reproductive Health

Collaborators

University of Cape Town, Tygerberg Hospital, Safe Abortion Action Fund of the International Planned Parenthood Federation, Society of Family Planning

1. Study Identification

Unique Protocol Identification Number

NCT01597726

Brief Title

Cervical Priming Before Dilation & Evacuation

Official Title

Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ibis Reproductive Health

Collaborators

University of Cape Town, Tygerberg Hospital, Safe Abortion Action Fund of the International Planned Parenthood Federation, Society of Family Planning

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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: 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) Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abortion, Induced

Keywords

Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Misoprostol

Arm Type

Active Comparator

Arm Title

Laminaria

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Laminaria

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of women with fetal expulsion prior to dilation and evacuation

Time Frame

Prior to D&E procedure

Secondary Outcome Measure Information:

Title

Proportion of women requiring additional dilation (manual or pharmacologic)

Time Frame

At time of D&E procedure

Title

Duration of dilation and evacuation procedure

Time Frame

End of D&E procedure

Title

Frequency of major complications

Description

Time Frame

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

Title

Frequency of Minor Complications

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judy Kluge, MBChB

Organizational Affiliation

Tygerberg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tygerberg Hospital

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

31029655

Citation

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.

Results Reference

derived

PubMed Identifier

24929888

Citation

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.

Results Reference

derived

Links:

URL

http://www.ibisreproductivehealth.org/

Description

Click here to visit the Ibis Reproductive Health website

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Cervical Priming Before Dilation & Evacuation

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