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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol group | Experimental | 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 |
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| Isosorbide Mononitrate Group | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 25 µg Vaginal | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Up to 40 hours post-intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Section | Rate of Cesarean Section Proportion of participants who underwent cesarean delivery. Unit of Measure: Percentage of participants (%) | during delivery |
| Postpartum Hemorrhage Unit of Measure: Number of participants |
Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Affiliation | Role |
|---|---|---|
| Wassan Nori, PhD | Al-Mustansiriyah University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yarmouk | Baghdad | 10052 | Iraq |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| C030397 | isosorbide-5-mononitrate |
| D020030 | Nitric Oxide Donors |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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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
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blinded assessors
|
|
| Isosorbide Mononitrate | Drug | 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. |
|
|
Number of participants with blood loss ≥500 mL during or within 2 hours after delivery.
| Delivery to 2 hours postpartum |
| abnormal fetal heart tracing during labor | number of fetuses who develop abnormal heart tracing | 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: 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 | 5 minutes post-delivery |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |