Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia
Condition: Preeclampsia; Labor, Premature
MeSH terms: Pre-Eclampsia; Obstetric Labor, Premature
Intervention: Monoket Pill; Placebo
Intervention description: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor; The pharmacy has compounded an identical appearing placebo
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 176.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Preeclampsia; Induction

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)
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  • 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.