Clinical trial NCT01597726: Cervical Priming Before Dilation & Evacuation
Official title: Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: Abortion, Induced
Laminaria
Misoprostol
Pregnancy Trimester, Second
Lead sponsor: Ibis Reproductive Health
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: Tygerberg Hospital
name: Safe Abortion Action Fund of the International Planned Parenthood Federation
name: Society of Family Planning
First posted: 2012-05-14
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

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

Primary outcomes:
measure: Proportion of women with fetal expulsion prior to dilation and evacuation
timeFrame: Prior to D&E procedure
Secondary outcomes:
measure: Proportion of women requiring additional dilation (manual or pharmacologic)
timeFrame: At time of D&E procedure
measure: Duration of dilation and evacuation procedure
timeFrame: End of D&E procedure
measure: Frequency of major complications
timeFrame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
measure: Frequency of Minor Complications
timeFrame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure)
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
Study officials:
affiliation: Tygerberg Hospital
name: Judy Kluge, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.