Cervical Ripening
Conditions
Keywords
Misoprostol, Isosorbide Mononitrate, Pregnancy, Prolonged
Brief summary
This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.
Detailed description
This randomized controlled trial evaluates the effectiveness and safety of misoprostol versus isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies (≥41+0 weeks gestation). Favorable cervical status, reflected by a Bishop Score ≥6, is critical for successful vaginal delivery. Participants are low-risk pregnant women at 41+6 weeks with an unfavorable cervix. They are randomized to receive either 25 mcg of vaginal misoprostol or 40 mg of vaginal IMN, administered every 4 hours for up to 3 doses. Cervical status is assessed at regular intervals to determine the achievement of cervical ripening within 40 hours. The primary outcome is the proportion of participants achieving a Bishop Score ≥6. Secondary outcomes include maternal parameters (labor progression, cesarean section rate, postpartum hemorrhage) and neonatal outcomes (Apgar scores, fetal heart rate tracing, and Doppler indices). The study aims to determine which agent more effectively facilitates cervical ripening and supports favorable delivery outcomes in late-term pregnancies.
Interventions
DRUGMisoprostol 25 µg Vaginal
The Misoprostol group (n=40) were Misoprostol cases, a synthetic PGE1 in the form of vaginal tablets of 25 µg (Vagiprost; ADWIA Co/Egypt) applied locally to the posterior fornix every 4 hours for cervical ripening before induction of labor is started (up to 3-doses).
The Isosorbide Mononitrate group (n=40) were nitric acid donor cases applied to the posterior fornix prior to induction of labor. Isosorbide mononitrate (IMN) (Monomack; Mack Pharmaceutics; Jordan) in a vaginal dose of 40 mg was used every 4 hours (up to 3 doses). Women who scored a BS of \> 6 from the assigned time were labelled as (1), after the passage of 40 hours, while those women whose BS was less than 6 were labelled (0) for construction of the Kaplan Meier curve for both groups.
Sponsors
Raid M. Al-Ani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
blinded assessors
Intervention model description
Arm 1 Arm Title: Misoprostol Group Arm Type: Experimental Arm Description: Participants in this group received 25 µg of Misoprostol (Vagiprost; ADWIA Co/Egypt) administered vaginally every 4 hours, up to a maximum of 3 doses, for cervical ripening before induction of labor. Assigned Intervention: Drug Name: Misoprostol • Other Names: Vagiprost, synthetic prostaglandin E1 Arm 2 Arm Title: Isosorbide Mononitrate Group Arm Type: Active Comparator Arm Description: Participants in this group received 40 mg of Isosorbide Mononitrate (Monomack; Mack Pharmaceutics, Jordan) administered vaginally every 4 hours, up to 3 doses, as a nitric oxide donor agent for cervical ripening. Assigned Intervention: Drug Name: Isosorbide Mononitrate • Other Names: IMN, Monomack, nitric oxide donor
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Low-risk primigravidae * Singleton viable pregnancy * Cephalic fetal presentation * Confirmed gestational age ≥ 41+0/7 weeks * Normal fetal growth pattern * No signs of labor at the time of enrollment
Exclusion criteria
* High-risk pregnancies * Body mass index (BMI) \> 30 kg/m² * History of unexplained fetal death * Oligohydramnios or fetal distress * Abnormal placentation * Rh-negative status * Pre-existing medical conditions or contraindications to labor induction or study drugs * Fetal abnormalities * Malpresentation or malposition * Inadequate pelvimetry * Participants who developed fetal distress or failed to progress during induction and required emergency cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Ripening Success | Time Frame: Up to 40 hours post-intervention | Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate. Unit of Measure: Percentage of participants (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cesarean Section | during delivery | Rate of Cesarean Section Proportion of participants who underwent cesarean delivery. Unit of Measure: Percentage of participants (%) |
| Postpartum Hemorrhage Unit of Measure: Number of participants | Delivery to 2 hours postpartum | Number of participants with blood loss ≥500 mL during or within 2 hours after delivery. |
| abnormal fetal heart tracing during labor | during delivery | number of fetuses who develop abnormal heart tracing |
| Neonatal Apgar Score <7 at 1 Minute Unit of Measure: Number of neonates | Time Frame: 1 minute post-delivery | Description: Number of neonates with Apgar score \<7 at 1 minute after birth. |
| Neonatal Apgar Score <10 at 5 Minutes | 5 minutes post-delivery | Number of neonates with Apgar score \<10 at 5 minutes after birth. Unit of Measure: Number of neonates |
Countries
Iraq
Outcome results
None listed