Clinical trial NCT03106389: Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
Official title: Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy Trimester, Second
Misoprostol
Catheters
Abortion, Second Trimester
Keywords: misoprostol
transcervical balloon catheter
second trimester
induced abortion
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. The second group will receive the same regimen, but in addition will have a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix. The target sample size is 108 cases randomized in a ratio of 1:1 using a computer-generated random sequence, allocation will be concealed in sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will be randomly assigned to one of the two groups.
Primary purpose: TREATMENT

Brief summary: This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).

Detailed description: The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive the standard misoprostol protocol for termination of second trimester pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours till complete expulsion of the uterine contents or surgical interference is decided. The second group will receive the exact same regimen, but will have in addition a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a computer-generated random sequence. Allocation will be concealed using sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will thus be randomly assigned to one of the groups.

Eligibility criteria: Inclusion Criteria: pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy.

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Exclusion Criteria:

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Primary outcomes:
measure: Induction-expulsion interval
timeFrame: 48 hours from starting intervention
Secondary outcomes:
measure: Total required doses of misoprostol
timeFrame: 48 hours from starting induction
measure: The need for surgical interventions
timeFrame: 1 week from starting induction
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Ain Shams University Maternity Hospital
state: Cairo
Study officials:
affiliation: AinShams University Maternity Hospital
name: Alaa Elfeky, Professor
role: PRINCIPAL_INVESTIGATOR
References: