NCT01597726

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

May 10, 2012

Last Update Submit

November 6, 2013

Conditions

Abortion, Induced

Keywords

Abortion, InducedLaminariaMisoprostolPregnancy Trimester, Second

Outcome Measures

Primary Outcomes (1)

  • Proportion of women with fetal expulsion prior to dilation and evacuation

    Prior to D&E procedure

Secondary Outcomes (4)

  • 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

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

  • Frequency of Minor Complications

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

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR
Drug: Misoprostol

Laminaria

EXPERIMENTAL
Device: Laminaria

Interventions

MisoprostolDRUG

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

Misoprostol
LaminariaDEVICE

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

Laminaria

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tygerberg Hospital

Cape Town, 7505, South Africa

Location

Related Publications (2)

  • 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.

    PMID: 31029655DERIVED

  • 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.

    PMID: 24929888DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Judy Kluge, MBChB

    Tygerberg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

ZA(1)