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Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions (MODE)

Primary Purpose

Cesarean Section, Misoprostol, Oxytocin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Misoprostol
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • Age > 18 years old

    • Singleton, or twins with demise of one
    • Cephalic presentation
    • Intact membranes
    • Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP)
    • Oligohydramnios (AFI< 5cm and/or MVP <2cm)
    • Fetal growth restriction (EFW or AC <10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers
    • Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal movement) prompting induction of labor
    • Suspected placental abruption
    • Poorly controlled pre-gestational diabetes, defined as >50% abnormal glucose values requiring increasing doses of anti-glycemic agents >34 weeks, or requiring delivery
    • Gestational Age > 22 weeks
    • Bishop score < 6

Exclusion Criteria:

  • • Prior cesarean delivery

    • Allergy to misoprostol
    • Allergy to oxytocin
    • Allergy to silicone/latex
    • Contraindication to vaginal delivery including placenta or vasa previa, Placenta accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load >1000 copies/mL

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxytocin with Mechanical Dilation

Misoprostol with Mechanical Dilation

Arm Description

If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement. If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation.

If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur

Outcomes

Primary Outcome Measures

Rate of Cesarean Delivery
Total rate of cesarean delivery

Secondary Outcome Measures

The time interval from induction-to-delivey for vaginal deliveries
Maternal outcome
The number of vaginal births within 24 hours
Maternal outcome
The number of misoprostol doses received by each participant
Maternal outcome
The incidence of uterine tachysystole
Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes
The rate of each indication for the cesarean delivery
Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.
The rate of operative vaginal delivery
Maternal outcome - includes forceps or vacuum assisted deliveries
The rate of intra-amniotic infection
Maternal outcome
The rate of postpartum hemorrhage
Maternal outcome
The rate of Fetal heart rate abnormaliies
recurrent late decelerations, bradycardia, or prolonged deceleration
The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection
Maternal outcome
The rate of stillbirth
Fetal/Neonatal outcome
The total rate of Neonatal Apgar scores less than 7 at 5 minutes
Neonatal outcome
The total rate of Neonatal RDS
Neonatal outcome
The total rate of Neonatal admission to the NICU
Neonatal outcome
The total rate of neonatal arterial umbilical blood pH < 7.1
Neonatal outcome
The rate of neonatal Sepsis
Neonatal outcome
The rate of Neonatal Death
Neonatal outcome

Full Information

First Posted
July 17, 2020
Last Updated
June 13, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04492072
Brief Title
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions
Acronym
MODE
Official Title
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise
Detailed Description
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation. In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Misoprostol, Oxytocin, High Risk Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin with Mechanical Dilation
Arm Type
Experimental
Arm Description
If the patient is randomized to Cook Balloon and Oxytocin - The balloon inflated to 60cc will be placed and oxytocin 2 mu/min will be initiated, and increased incrementally by 2mu/min every 30 minutes. If the cook cannot be placed initially, it will be reattempted and placed within 6 hours of oxytocin starting. The Cook catheter will remain in place until spontaneously expelled, or if not, after 12 hours of placement. If a Cook Balloon is not available, a Foley catheter can be used in its place as alternate and equivalent form of mechanical dilation.
Arm Title
Misoprostol with Mechanical Dilation
Arm Type
Active Comparator
Arm Description
If the patient is randomized to Misoprostol and Cook balloon - she will be given 25mcg of misoprostol orally or buccal and a Cook Balloon inflated to 60cc will be placed. She will subsequently receive 50mcg oral or buccal misoprostol every 4 hours up to 4 doses. If regular contractions occur (three or more contractions in a 10-minute period), the patient will be switched to Oxytocin 2 mu/min, and increased incrementally by 2mu/min every 30 minutes. If the cook balloon cannot be placed initially, it will be reattempted and placed within 6 hours of induction start. The Cook catheter will remain in place until spontaneously expelled, or at the fourth misoprostol administration. At this point, oxytocin will be started if not already initiated and artificial rupture of membranes will occur
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Mechanical Dilation
Intervention Description
Intervention
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Mechanical Dilation
Intervention Description
Control
Primary Outcome Measure Information:
Title
Rate of Cesarean Delivery
Description
Total rate of cesarean delivery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
The time interval from induction-to-delivey for vaginal deliveries
Description
Maternal outcome
Time Frame
48 hours
Title
The number of vaginal births within 24 hours
Description
Maternal outcome
Time Frame
24 hours
Title
The number of misoprostol doses received by each participant
Description
Maternal outcome
Time Frame
24 hours
Title
The incidence of uterine tachysystole
Description
Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes
Time Frame
24 hours
Title
The rate of each indication for the cesarean delivery
Description
Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.
Time Frame
48 hours
Title
The rate of operative vaginal delivery
Description
Maternal outcome - includes forceps or vacuum assisted deliveries
Time Frame
48 hours
Title
The rate of intra-amniotic infection
Description
Maternal outcome
Time Frame
48 hours
Title
The rate of postpartum hemorrhage
Description
Maternal outcome
Time Frame
24 hours
Title
The rate of Fetal heart rate abnormaliies
Description
recurrent late decelerations, bradycardia, or prolonged deceleration
Time Frame
48 hours
Title
The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection
Description
Maternal outcome
Time Frame
24 hours
Title
The rate of stillbirth
Description
Fetal/Neonatal outcome
Time Frame
48 hours
Title
The total rate of Neonatal Apgar scores less than 7 at 5 minutes
Description
Neonatal outcome
Time Frame
5 minutes
Title
The total rate of Neonatal RDS
Description
Neonatal outcome
Time Frame
96 hours
Title
The total rate of Neonatal admission to the NICU
Description
Neonatal outcome
Time Frame
96 hours
Title
The total rate of neonatal arterial umbilical blood pH < 7.1
Description
Neonatal outcome
Time Frame
96 hours
Title
The rate of neonatal Sepsis
Description
Neonatal outcome
Time Frame
96 hours
Title
The rate of Neonatal Death
Description
Neonatal outcome
Time Frame
96 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Age > 18 years old Singleton, or twins with demise of one Cephalic presentation Intact membranes Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP) Oligohydramnios (AFI< 5cm and/or MVP <2cm) Fetal growth restriction (EFW or AC <10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal movement) prompting induction of labor Suspected placental abruption Poorly controlled pre-gestational diabetes, defined as >50% abnormal glucose values requiring increasing doses of anti-glycemic agents >34 weeks, or requiring delivery Gestational Age > 22 weeks Bishop score < 6 Exclusion Criteria: • Prior cesarean delivery Allergy to misoprostol Allergy to oxytocin Allergy to silicone/latex Contraindication to vaginal delivery including placenta or vasa previa, Placenta accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load >1000 copies/mL
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions

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