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Completed

NCT Number: NCT04492072

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Intervention

Other names: Mechanical Dilation

Misoprostol

Drug

Control

Other names: Mechanical Dilation

Primary outcomes

  1. Rate of Cesarean Delivery

    Time frame: 48 hours

    Total rate of cesarean delivery

Secondary outcomes

  1. The time interval from induction-to-delivey for vaginal deliveries

    Time frame: 48 hours

    Maternal outcome

  2. The number of vaginal births within 24 hours

    Time frame: 24 hours

    Maternal outcome

  3. The number of misoprostol doses received by each participant

    Time frame: 24 hours

    Maternal outcome

  4. The incidence of uterine tachysystole

    Time frame: 24 hours

    Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes

  5. The rate of each indication for the cesarean delivery

    Time frame: 48 hours

    Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.

  6. The rate of operative vaginal delivery

    Time frame: 48 hours

    Maternal outcome - includes forceps or vacuum assisted deliveries

  7. The rate of intra-amniotic infection

    Time frame: 48 hours

    Maternal outcome

  8. The rate of postpartum hemorrhage

    Time frame: 24 hours

    Maternal outcome

  9. The rate of Fetal heart rate abnormaliies

    Time frame: 48 hours

    recurrent late decelerations, bradycardia, or prolonged deceleration

  10. The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection

    Time frame: 24 hours

    Maternal outcome

  11. The rate of stillbirth

    Time frame: 48 hours

    Fetal/Neonatal outcome

  12. The total rate of Neonatal Apgar scores less than 7 at 5 minutes

    Time frame: 5 minutes

    Neonatal outcome

  13. The total rate of Neonatal RDS

    Time frame: 96 hours

    Neonatal outcome

  14. The total rate of Neonatal admission to the NICU

    Time frame: 96 hours

    Neonatal outcome

  15. The total rate of neonatal arterial umbilical blood pH < 7.1

    Time frame: 96 hours

    Neonatal outcome

  16. The rate of neonatal Sepsis

    Time frame: 96 hours

    Neonatal outcome

  17. The rate of Neonatal Death

    Time frame: 96 hours

    Neonatal outcome

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial

Acronym: MODE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2020
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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