Induction of Labor in Morbidly Obese Patients
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
Speaks English or Spanish
Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
Age 18 years old or older
Disqualifiers
History of cesarean delivery
Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
Contraindications to labor (cardiac, neurosurgical, need for cesarean)
Trial design
Design model
Parallel
Treatments tested in this trial
Misoprostol
DrugParticipants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: Control - 25 mcg vaginal misoprostolActive comparator 1 intervention
Group B: Intervention - 50 mcg vaginal misoprostolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Achievement of complete cervical dilation
Time frame
Start of IOL until complete dilationSecondary outcomes
1
Time interval from start of induction of labor (IOL) to complete cervical dilation
Time frame
Start of IOL until complete dilation2
Achievement of 6 cm cervical dilation/active labor
Time frame
Start of IOL until 6 cm dilation3
Time interval from start of IOL to 6 cm cervical dilation/active labor
Time frame
Start of IOL until 6 cm dilation4
Time interval from start of IOL to vaginal delivery
Time frame
Start of IOL until deliverySponsors and contacts
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Source ClinicalTrials.gov