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Completed

NCT Number: NCT01597726

Cervical Priming Before Dilation & Evacuation

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

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Key information

Conditions

Abortion, Induced Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tygerberg Hospital

Cape Town, 7505, South Africa

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

laminaria

Device

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

Primary outcomes

  1. Proportion of women with fetal expulsion prior to dilation and evacuation

    Time frame: Prior to D&E procedure

Secondary outcomes

  1. Proportion of women requiring additional dilation (manual or pharmacologic)

    Time frame: At time of D&E procedure

  2. Duration of dilation and evacuation procedure

    Time frame: End of D&E procedure

  3. Frequency of major complications

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

    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

  4. Frequency of Minor Complications

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

    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

Sponsors and collaborators

Lead sponsor

Ibis Reproductive Health

Other

Collaborators

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

Registry information

Official study title

Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 14, 2012
Registry last updated
Nov 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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