Pregnancy Clinical Trial
Official title:
A Cluster Randomized Trial of Labor Induction With Oral Versus Vaginal Misoprostol
NCT number | NCT04755218 |
Other study ID # | STU 2020-1395 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | July 7, 2023 |
Verified date | April 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2546 |
Est. completion date | July 7, 2023 |
Est. primary completion date | September 18, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 10 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health and Hospital Systems | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Vaginal Delivery | vaginal delivery at first induction | at delivery | |
Secondary | Time to Delivery | time (in hours) from start of induction agent to delivery at first induction | from start of induction agent to time of delivery | |
Secondary | Time (hours) of Oxytocin | time (in hours) from start of Oxytocin until turned off for delivery | at delivery | |
Secondary | Need for Oxytocin | administration of Oxytocin to facilitate labor contractions | at delivery | |
Secondary | Indication for Cesarean Delivery | among women delivered by cesarean, the indication for cesarean | at delivery | |
Secondary | Use of Epidural During Labor | use of epidural between the start of induction and delivery | at delivery | |
Secondary | Presence of Chorioamnionitis | intrapartum fever (temp greater than or equal to 38 degrees C) with clinical concern for infection and no other identified cause | at delivery | |
Secondary | Number of Participants with Uterine Hyperstimulation Syndrome | tachysystole accompanied by fetal heart rate decelerations | at delivery | |
Secondary | Number of Participants with Excess Blood Loss | Maternal excess blood loss is defined as >500mL for vaginal and >1000mL for cesarean delivery | at delivery | |
Secondary | Number of Participants with Blood Transfusion | administration of blood products related to delivery blood loss | at delivery | |
Secondary | Number of Participants with Puerperal Fever and/or Endometritis | maternal fever recorded in the time after delivery, but prior to discharge from the hospital, with or without clinical assessment of endometritis | immediately after delivery to discharge from the hospital, or up to 4 weeks postpartum | |
Secondary | Surgical Site Infection | documentation of cellulitis, organisms grown on wound culture, or superficial or deep space surgical site infection with or without purulent drainage requiring readmission | from time of birth until the time of discharge, or up to 4 weeks postpartum | |
Secondary | Number of Participants with Uterine Rupture | spontaneous separation of myometrium in a previously intact, unscarred uterus | at delivery | |
Secondary | Number of Participants with Unplanned Hysterectomy | unplanned removal of the uterus following delivery of the fetus | immediately after delivery to discharge from the hospital, or up to 4 weeks postpartum | |
Secondary | Number of Participants with Meconium-Stained Amniotic Fluid | identification of any meconium (green tinge) in the amniotic fluid before or during delivery by a healthcare provider's assessment of gross fluid color | at the time of rupture of membranes or at delivery | |
Secondary | Number of Participants with Umbilical pH <7.0 | arterial or venous cord blood pH defined as < 7.0 | at delivery | |
Secondary | Number of Participants with a 5-minute Apgar Score Less Than 4 | Appearance, Pulse, Grimace, Activity, Respirations-scored from 0-2 for each component, added to make a total score and used as an assessment of initial response to newborn resuscitation, lower scores associated with poor outcomes. Here defined as Apgar <4 at 5 minutes | 5 minutes after time of birth | |
Secondary | Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No) | intubation with mechanical support or control of neonatal breathing in the delivery room | at delivery | |
Secondary | Number of Participants with Neonatal Sepsis | neonatal bacteremia as defined by bacterial growth in blood cultures | from time of birth until time of discharge or up to 7 days of life, whichever comes first | |
Secondary | Number of Participants with NICU Admission Order | admission order to neonatal intensive care unit (NICU) placed between the time of delivery and infant discharge | from time of birth until the time of discharge or up to 7 days of life, whichever comes first. |
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