Cervical Priming Before Dilation & Evacuation

This study has been completed.
Sponsor:
Collaborators:
University of Cape Town
Tygerberg Hospital
Safe Abortion Action Fund of the International Planned Parenthood Federation
Society of Family Planning
Information provided by (Responsible Party):
Ibis Reproductive Health
ClinicalTrials.gov Identifier:
NCT01597726
First received: May 10, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Abortion, Induced
Drug: Misoprostol
Device: Laminaria

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ibis Reproductive Health:

Primary Outcome Measures:
  • Proportion of women with fetal expulsion prior to dilation and evacuation [ Time Frame: Prior to D&E procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of women requiring additional dilation (manual or pharmacologic) [ Time Frame: At time of D&E procedure ] [ Designated as safety issue: No ]
  • Duration of dilation and evacuation procedure [ Time Frame: End of D&E procedure ] [ Designated as safety issue: No ]
  • Frequency of major complications [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ] [ Designated as safety issue: Yes ]

    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


Enrollment: 159
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597726

Locations
South Africa
Tygerberg Hospital
Cape Town, South Africa, 7505
Sponsors and Collaborators
Ibis Reproductive Health
University of Cape Town
Tygerberg Hospital
Safe Abortion Action Fund of the International Planned Parenthood Federation
Society of Family Planning
Investigators
Principal Investigator: Judy Kluge, MBChB Tygerberg Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ibis Reproductive Health
ClinicalTrials.gov Identifier: NCT01597726     History of Changes
Other Study ID Numbers: 32020
Study First Received: May 10, 2012
Last Updated: November 6, 2013
Health Authority: South Africa: Medicines Control Council

Keywords provided by Ibis Reproductive Health:
Abortion, Induced
Laminaria
Misoprostol
Pregnancy Trimester, Second

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 20, 2014