Labor Induction With Oral Versus Vaginal Misoprostol

NCT ID: NCT04755218

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2546 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2023-07-07

Brief Summary

This study will compare vaginal and oral misoprostol, to determine whether a vaginal misoprostol regimen achieves a higher vaginal delivery rate in a real-world, high-volume setting, and whether this regimen reduces time and oxytocin need on a high-volume Labor and Delivery unit at Parkland Hospital.

Our primary hypothesis is that among women with singleton, term pregnancies, cervical dilation 2cm or less, and indicated labor induction, the rate of vaginal delivery is significantly increased when a standardized vaginal misoprostol regimen is used, compared with a standardized oral misoprostol regimen.

Detailed Description

The purpose of this study is to determine whether the use of a standardized vaginal misoprostol regimen will result in a decreased primary cesarean delivery rate among women with a cervical dilation of 2 centimeters of less who require induction of labor at term, compared with the currently used oral misoprostol regimen. We also aim to evaluate oxytocin use, time to delivery, uterine activity, indication for cesarean delivery, intrapartum and postpartum infectious morbidities, excess blood loss at delivery, and adverse neonatal outcomes in the overall population as well as nulliparous women specifically.

This will be a prospective, cluster-randomized clinical trial to compare the rate of vaginal delivery achieved when two standards of care are used across a large population of women with indication for labor induction at Parkland Hospital. Eligible participants will include nulliparous and multiparous women at 37 weeks gestation or greater, with a living, singleton fetus and no major fetal malformations, in cephalic presentation, with intact membranes, no prior uterine scar, who qualify for prostaglandin administration and who have a cervical dilation of 2 centimeters or less, measured at the level of the internal os. Patients with non-reassuring fetal status, active herpes outbreak, a prior uterine scar, or any contraindication to prostaglandins (including 4 or more painful contractions per 10 minutes prior to prostaglandin administration) will be excluded from participation in the study.

Computer-generated cluster randomization will occur on a weekly basis for all study participants, to either the vaginal misoprostol regimen (study group) or to oral misoprostol regimen (control group).

According to the randomization protocol each week, participants will be randomized to either the oral misoprostol standard of care (control group) or vaginal misoprostol standard of care (study group). The study group will receive vaginal misoprostol 25 mcg every 3 hours for a maximum of 5 doses in those who meet criteria for prostaglandin administration. The control group will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Misoprostol will not be administered to patients who have progressed to active labor, defined as 4 centimeters cervical dilation. Intravenous oxytocin will be administered according to current PHHS protocol for both groups.

No direct contact between the research team and patients will be required, as this is a systematic comparison of two standards of care.

The primary outcome will be the rate of vaginal delivery.

Secondary outcomes will include maternal and neonatal outcomes.

Maternal outcomes will include time to delivery, time (hours) of oxytocin, need for oxytocin, indication for cesarean delivery, labor analgesia, clinical chorioamnionitis, tachysystole, hyperstimulation syndrome, excess estimated blood loss, transfusion at delivery, endometritis, surgical site infection, uterine rupture, and unplanned hysterectomy.

Neonatal outcomes will include meconium-stained amniotic fluid, umbilical cord pH <7.0, 5-minute Apgar <4, neonatal intubation or ventilation in the delivery room, neonatal sepsis, and neonatal intensive care (NICU) admission.

Conditions

Pregnancy; Labor, Induced

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Vaginal Misoprostol

Patients will receive vaginal misoprostol 25 micrograms given every 3 hours for a maximum of 5 doses. Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States

No interventions assigned to this group

Oral Misoprostol

Patients will receive standard oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses according to current labor induction protocol

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Nulliparous and multiparous pregnant women
• 37 weeks gestation or greater
• Living, singleton fetus
• No major fetal malformations
• Cephalic presentation
• No prior uterine scar
• Intact fetal membranes
• Qualifies for prostaglandin administration according to current Parkland protocol
• Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os
• Have an indication for induction or attempted induction of labor according to Parkland protocol

Exclusion Criteria

• Non-reassuring fetal status
• Active herpes outbreak
• Prior uterine scar
• Contraindication to prostaglandins according to current Parkland protocol (including 4 or more painful contractions per 10 min prior to prostaglandin administration)
• Contraindication to vaginal delivery

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Emily Adhikari

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily H Adhikari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health and Hospital Systems

Dallas, Texas, United States

Countries

United States

References

Adhikari EH, McGuire J, Lo J, McIntire DD, Spong CY, Nelson DB. Vaginal Compared With Oral Misoprostol Induction at Term: A Cluster Randomized Controlled Trial. Obstet Gynecol. 2024 Feb 1;143(2):256-264. doi: 10.1097/AOG.0000000000005464. Epub 2023 Nov 21.

Reference Type: DERIVED

PMID: 37989142 (View on PubMed)

Other Identifiers

STU 2020-1395

Identifier Type: -

Identifier Source: org_study_id