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Induction of Labor in Morbidly Obese Patients

Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two doses of misoprostol (25 mcg and 50 mcg), a drug used to start labor. It is for pregnant adults with a BMI of 40 or higher, a measure of body size based on height and weight. The goal is to see whether the dose affects the chance of a vaginal birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI of 40 or higher when admitted to start labor.
  • Speak English or Spanish.
  • Be between 34 weeks, 0 days and 42 weeks, 6 days pregnant.
  • Be age 18 or older.
  • Be carrying one living baby who is head-down.
  • Plan to use medicine to soften and open the cervix (the opening to the womb), with the cervix less than 5 cm open.
  • Have fewer than 5 contractions in 10 minutes.

Who can't join

  • Have had a C-section or major surgery to remove growths called fibroids from the womb, or cannot safely receive prostaglandin drugs used to start labor.
  • Cannot safely have a vaginal birth because the placenta or the baby's blood vessels cover the cervix, or because of HIV with a high amount of virus in the blood.
  • Cannot safely go through labor because of a heart or brain surgery-related condition, or need a C-section.
  • Are under age 18, have a cervix more than 5 cm open, or have more than 5 contractions in 10 minutes.
  • The baby is growing too slowly and has an abnormal blood flow test in the umbilical cord.
  • Have heavy vaginal bleeding that may mean the placenta is pulling away from the womb.
  • The baby shows signs of distress or drops in heart rate, has died, or has a major problem with how the body formed.
  • Cannot give consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * Viable, single, cephalic fetus * Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm * Contractions \< 5 per 10 minutes Exclusion Criteria: * 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) * Age \< 18yo * Fetal growth restriction with abnormal umbilical artery Doppler indices * Cervical dilation \>5 cm * Contractions \>5 per 10 minutes * Significant vaginal bleeding with concern for placental abruption * Non-reassuring fetal status or fetal heart rate decelerations * Fetal demise or major fetal anomaly * Inability to give consent

Study sites (1)

MD