Clinical trial · Interventional
Cervical Priming Before Dilation & Evacuation
Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial
NCT01597726CI-TRIAL-00012597completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abortion, Induced | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laminaria | Device | — | UNRESOLVED |
| Misoprostol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Misoprostol
- interventionNames
- Drug: Misoprostol
- type
- EXPERIMENTAL
- label
- Laminaria
- interventionNames
- Device: Laminaria
Primary outcomes (1)
- measure
- Proportion of women with fetal expulsion prior to dilation and evacuation
- timeFrame
- Prior to D&E procedure
Secondary outcomes (4)
- measure
- Proportion of women requiring additional dilation (manual or pharmacologic)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDConstant 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. PMID 31029655
- DERIVEDGrossman 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. PMID 24929888