NCT03171480

Brief Summary

A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN) versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia (≥24/0 weeks' gestation)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

May 10, 2017

Results QC Date

August 5, 2021

Last Update Submit

December 7, 2021

Conditions

PreeclampsiaLabor, Premature

Keywords

PreeclampsiaInduction

Outcome Measures

Primary Outcomes (1)

  • Cesarean Delivery Rate

    Rate of cesarean section for those enrolled in study

    7 days

Secondary Outcomes (1)

  • Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid

    during the induction of labor till delivery for all outcomes

Study Arms (2)

Monoket pill

EXPERIMENTAL

Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris\[1\] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,

Drug: Monoket Pill

Placebo pill

PLACEBO COMPARATOR

The pharmacy has compounded an identical appearing placebo

Drug: Placebo

Interventions

Monoket PillDRUG

Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor

Also known as: Isosorbide mononitrate
Monoket pill
PlaceboDRUG

The pharmacy has compounded an identical appearing placebo

Placebo pill

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnant women with preeclampsia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women older than 18 years at the time of induction of labor with the ability to give informed consent
  • Induction of labor for clinical diagnosis of preeclampsia
  • Unfavorable cervix (Bishop's score of less than 6)
  • Cervical dilation 2cm or less
  • Singleton
  • Gestational age ≥ 24 weeks
  • English speaking

You may not qualify if:

  • Contraindication to vaginal delivery
  • Contraindication to misoprostol
  • Fetal Demise
  • Major fetal anomaly
  • Non-english speaking women
  • HIV
  • Medical conditions requiring assisted second stage
  • Category III tracing
  • Eclampsia
  • Hemolysis Elevated Liver enzymes Low Platelets syndrome
  • DIC or active hemorrhage before randomization
  • Hypersensitivity to isosorbide mononitrate
  • Isosorbide mononitrate should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g following a head trauma and including cerebral hemorrhage.
  • Isosorbide mononitrate should not be used in patients with severe anemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
  • Isosorbide mononitrate tablets contain lactose and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State Medical Center Labor and Delivery Unit

Columbus, Ohio, 43210, United States

Location

Related Publications (7)

  • Buhimschi I, Ali M, Jain V, Chwalisz K, Garfield RE. Differential regulation of nitric oxide in the rat uterus and cervix during pregnancy and labour. Hum Reprod. 1996 Aug;11(8):1755-66. doi: 10.1093/oxfordjournals.humrep.a019481.

    PMID: 8921128BACKGROUND

  • Ghosh A, Lattey KR, Kelly AJ. Nitric oxide donors for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2016 Dec 5;12(12):CD006901. doi: 10.1002/14651858.CD006901.pub3.

    PMID: 27918616BACKGROUND

  • Chanrachakul B, Herabutya Y, Punyavachira P. Randomized trial of isosorbide mononitrate versus misoprostol for cervical ripening at term. Int J Gynaecol Obstet. 2002 Aug;78(2):139-45. doi: 10.1016/s0020-7292(02)00128-5.

    PMID: 12175715BACKGROUND

  • El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.

    PMID: 25694257BACKGROUND

  • Thomson AJ, Lunan CB, Cameron AD, Cameron IT, Greer IA, Norman JE. Nitric oxide donors induce ripening of the human uterine cervix: a randomised controlled trial. Br J Obstet Gynaecol. 1997 Sep;104(9):1054-7. doi: 10.1111/j.1471-0528.1997.tb12066.x.

    PMID: 9307534BACKGROUND

  • Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. 2010 Jul;116(1):121-126. doi: 10.1097/AOG.0b013e3181e408f2.

    PMID: 20567177RESULT

  • Gee SE, Ma'ayeh M, Cackovic H, Samuels P, Thung SF, Landon MB, Rood KM. Addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive diseases of pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100343. doi: 10.1016/j.ajogmf.2021.100343. Epub 2021 Feb 27.

    PMID: 33652160DERIVED

MeSH Terms

Conditions

Pre-EclampsiaObstetric Labor, Premature

Interventions

isosorbide-5-mononitrate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor Complications

Results Point of Contact

Title
Kara Rood, MD
Organization
The Ohio State University
kara.rood@osumc.edu
440-321-0264

Study Officials

  • Kara Rood, MD

    The Ohio State Wexner Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A double blinded, placebo controlled, randomized clinical trial of patients undergoing induction of labor for preeclampsia. Study drug or identical appearing placebo will be delivered to labor floor by pharmacist, after randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 31, 2017

Study Start

October 30, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 4, 2022

Results First Posted

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)