An interventional study of Misoprostol 25 µg Vaginal and Isosorbide Mononitrate in Cervical Ripening, sponsored by Raid M. Al-Ani. Active, not recruiting at 1 site in Iraq. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Raid M. Al-Ani · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Pregnancy, Prolonged; 2 are open to participants now.
This study's enrollment of 80 is below the median of 132 across 23 interventional studies indexed under Pregnancy, Prolonged.
Browse Pregnancy, Prolonged studies →This is the only study on the registry with Raid M. Al-Ani as lead sponsor.
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Exclusion Criteria:
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
Drug: Misoprostol 25 µg Vaginal
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).
Drug: Isosorbide Mononitrate
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).
Also known as: Cytotec Vagiprost PGE1 analogue
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.
Also known as: IMN, Monomack, Nitric oxide donor
Cervical Ripening Success
Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate. Unit of Measure: Percentage of participants (%)
Time frame: Time Frame: Up to 40 hours post-intervention
Cesarean Section
Rate of Cesarean Section Proportion of participants who underwent cesarean delivery. Unit of Measure: Percentage of participants (%)
Time frame: during delivery
Postpartum Hemorrhage Unit of Measure: Number of participants
Number of participants with blood loss ≥500 mL during or within 2 hours after delivery.
Time frame: Delivery to 2 hours postpartum
abnormal fetal heart tracing during labor
number of fetuses who develop abnormal heart tracing
Time frame: during delivery
Neonatal Apgar Score <7 at 1 Minute Unit of Measure: Number of neonates
Description: Number of neonates with Apgar score \<7 at 1 minute after birth.
Time frame: Time Frame: 1 minute post-delivery
Neonatal Apgar Score <10 at 5 Minutes
Number of neonates with Apgar score \<10 at 5 minutes after birth. Unit of Measure: Number of neonates
Time frame: 5 minutes post-delivery
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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