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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Pitocin or Oral Misoprostol for PROM IOL

Short name POM PROM

NCTNCT04028765 (opens ClinicalTrials.gov in a new tab)Other id833536
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
108 participants (actual)
Sponsor
University of Pennsylvania · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
12 Aug 2019
Primary completion
8 Dec 2022
Completion
8 Jan 2023
First posted
23 Jul 2019
Last update posted
30 Apr 2024
Conditions
PROM

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 4

    POM PROM

    NCT04028765

    12 Aug 2019 to 8 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.

Interventions

  • MisoprostolDrug
  • OxytocinDrug

Arms2

  • Active comparator

    Oral Misoprostol

  • Active comparator

    Oxytocin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time From Induction of Labor (IOL) to Delivery

    Time frame · Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.

    Registry description

    Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.

Secondary outcomes(7)

  1. Infection

    Time frame · Enrollment to Delivery

    Registry description

    Suspected intraamniotic infection

  2. Time From Premature Rupture of Membranes (PROM) to Delivery

    Time frame · Time (hours) from PROM (as reported by patient) to delivery of infant

  3. Time From IOL to Vaginal Delivery

    Time frame · Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery

  4. Time From PROM to Vaginal Delivery

    Time frame · Time (hours) from PROM (as reported by patient) to vaginal delivery

  5. Cesarean Delivery

    Time frame · Enrollment to Delivery

    Registry description

    Cesarean section rate

  6. Maternal Morbidity

    Time frame · Enrollment to 4 weeks postpartum

    Registry description

    Composite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death

  7. Neonatal Morbidity

    Time frame · Enrollment to hospital discharge (On average 2-4 days)

    Registry description

    Composite neonatal morbidity: NICU admission \> 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.

Time From Induction of Labor (IOL) to Delivery

GroupValue (Hours)
Oral Misoprostol18.1
Oxytocin14.9
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Enrollment to Delivery

Infection

GroupValue (Participants)
Oral Misoprostol8
Oxytocin6
Secondary outcomeMedian· Time (hours) from PROM (as reported by patient) to delivery of infant

Time From Premature Rupture of Membranes (PROM) to Delivery

GroupValue (Hours)
Oral Misoprostol25.8
Oxytocin22.1
Secondary outcomeMedian· Time from IOL (as defined by receipt of first medication for induction) to vaginal delivery

Time From IOL to Vaginal Delivery

GroupValue (Hours)
Oral Misoprostol17.9
Oxytocin12.9
Secondary outcomeMedian· Time (hours) from PROM (as reported by patient) to vaginal delivery

Time From PROM to Vaginal Delivery

GroupValue (Hours)
Oral Misoprostol24.9
Oxytocin21.6
Secondary outcomeCount of participants· Enrollment to Delivery

Cesarean Delivery

GroupValue (Participants)
Oral Misoprostol13
Oxytocin14
Secondary outcomeCount of participants· Enrollment to 4 weeks postpartum

Maternal Morbidity

GroupValue (Participants)
Oral Misoprostol8
Oxytocin9
Secondary outcomeCount of participants· Enrollment to hospital discharge (On average 2-4 days)

Neonatal Morbidity

GroupValue (Participants)
Oral Misoprostol1
Oxytocin2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral Misoprostol-MothersMisoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Maternal Events Only0 / 520 / 523 / 52
Oxytocin-MothersOxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Maternal Events only0 / 560 / 563 / 56
Oral Misoprostol-Fetus/NeonateMisoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Neonatal Events Only0 / 521 / 521 / 52
Oxytocin-Fetus/NeonateOxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Neonatal Events only0 / 560 / 562 / 56

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

More studies

7 studies on this page

Indexing hint: Randomized controlled trial · 2014

EFFECTIVENESS AND SAFETY OF 2-HOURLY 20 MCG ORAL MISOPROSTOL SOLUTION COMPARED TO STANDARD INTRAVENOUS OXYTOCIN IN LABOUR INDUCTION DUE TO PRE-LABOUR RUPTURE OF MEMBRANES AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL.

Mbaluka et al. 2014East African medical journalcited by 10

PMID 26866082PUB-26866082

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2003

Oral misoprostol vs. intravenous oxytocin for labor induction in women with prelabor rupture of membranes at term.

Al-Hussaini et al. 2003International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetricscited by 14

PMID 12834947DOI 10.1016/s0020-7292(03)00136-xPUB-12834947

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2003

Oral misoprostol for premature rupture of membranes at term.

Crane et al. 2003American journal of obstetrics and gynecologycited by 24

PMID 14526301DOI 10.1067/s0002-9378(03)00768-3PUB-14526301

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2003

The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term.

Mozurkewich et al. 2003American journal of obstetrics and gynecologycited by 22

PMID 14586349DOI 10.1067/s0002-9378(03)00845-7PUB-14586349

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2000

Labour characteristics and uterine activity: misoprostol compared with oxytocin in women at term with prelabour rupture of the membranes.

Ngai et al. 2000BJOG : an international journal of obstetrics and gynaecologycited by 42

PMID 10688506DOI 10.1111/j.1471-0528.2000.tb11693.xPUB-10688506

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 1999

Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture.

Butt et al. 1999Obstetrics and gynecologycited by 33

PMID 10576189DOI 10.1016/s0029-7844(99)00423-8PUB-10576189

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1996

Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group.

Hannah et al. 1996The New England journal of medicinecited by 256

PMID 8598837DOI 10.1056/nejm199604183341601PUB-08598837

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * English Speaking * PROM \</= 24 hours with no evidence of labor * \>/= 36 weeks gestation * Agreeable to induction of labor * Nulliparous * Singleton pregnancy * Vertex presentation * Cervical dilation \</=2 cm AND Bishop score \< 8 Exclusion Criteria: * Prior cesarean section * Other contraindication to vaginal delivery * Intrauterine Fetal Demise * Major Congenital Anomaly * Intraamniotic infection diagnosed at time of admission * 36 weeks - 36 weeks and 6 days with unknown Group B Strep (GBS) status

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