Abortion, Induced
Conditions
Keywords
Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second
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
Interventions
DRUGMisoprostol
Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose if needed
DEVICELaminaria
Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E
Sponsors
University of Cape Town
Tygerberg Hospital
Safe Abortion Action Fund of the International Planned Parenthood Federation
Society of Family Planning
Ibis Reproductive Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women with fetal expulsion prior to dilation and evacuation | Prior to D&E procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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 |
Countries
South Africa
Outcome results
None listed