Trial Outcomes & Findings for Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia (NCT NCT03171480)

NCT ID: NCT03171480

Last Updated: 2022-01-04

Results Overview

Rate of cesarean section for those enrolled in study

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 176 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2022-01-04

Participant Flow

Participant milestones

Measure	Monoket Pill 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, Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor	Placebo The pharmacy has compounded an identical appearing placebo Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
Overall Study STARTED	89	87
Overall Study COMPLETED	89	87
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Monoket Pill n=89 Participants 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, Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor	Placebo Pill n=87 Participants The pharmacy has compounded an identical appearing placebo Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=89 Participants	0 Participants n=87 Participants	0 Participants n=176 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=89 Participants	87 Participants n=87 Participants	176 Participants n=176 Participants
Age, Categorical >=65 years	0 Participants n=89 Participants	0 Participants n=87 Participants	0 Participants n=176 Participants
Age, Continuous	28 years n=89 Participants	27 years n=87 Participants	28 years n=176 Participants
Sex: Female, Male Female	89 Participants n=89 Participants	87 Participants n=87 Participants	176 Participants n=176 Participants
Sex: Female, Male Male	0 Participants n=89 Participants	0 Participants n=87 Participants	0 Participants n=176 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 7 days

Rate of cesarean section for those enrolled in study

Outcome measures

Measure	Monoket Pill n=89 Participants 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, Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor	Placebo n=87 Participants The pharmacy has compounded an identical appearing placebo Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
Cesarean Delivery Rate	29 Participants	22 Participants

SECONDARY outcome

Timeframe: during the induction of labor till delivery for all outcomes

placenta abruption at time of delivery, administration of IV antihypertensive medication for BP >160/110, maternal hypotensive defined as <90/50, Uterine hyperstimulation defined as >3 contractions in 10 minutes and meconium stained amniotic fluid anytime during labor induction/augmentation

Outcome measures

Measure	Monoket Pill n=89 Participants 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, Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor	Placebo n=87 Participants The pharmacy has compounded an identical appearing placebo Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid Abruption	0 Participants	0 Participants
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid Anti-hypertensives	29 Participants	32 Participants
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid hypotension	9 Participants	8 Participants
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid uterine hyperstimulation	3 Participants	1 Participants
Placental Abruption, Use of IV Antihypertensive Drug, Maternal Hypotension, Uterine Hyperstimulation and Meconium Stained Fluid MSAF	0 Participants	0 Participants

Adverse Events

Monoket Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kara Rood, MD

The Ohio State University

Phone: 440-321-0264

Email: kara.rood@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place