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This clinical trial aims to determine whether giving intravenous dexamethasone can shorten the time it takes for women to deliver after labor induction in term pregnancies with pre-labour rupture of membranes (PROM). PROM refers to the breaking of the water at least one hour before the start of labor contractions. When this occurs at term, labor is often induced to reduce risks to both mother and baby.
The main question this study seeks to answer is: Does intravenous dexamethasone reduce the time from the start of labor induction to delivery compared to a placebo?
Researchers hypothesize that women who receive dexamethasone will have a shorter induction-to-delivery time than those who receive a placebo.
To test this, 60 first-time pregnant women (primigravida), aged 18 to 45 years, with a single full-term pregnancy and PROM will be enrolled. Participants will be randomly assigned into two groups. One group will receive 8 mg intravenous dexamethasone, while the other group will receive a placebo (normal saline), both administered one hour before labor induction.
Labor will be induced using standard medications, including vaginal prostaglandin (misoprostol) followed by oxytocin infusion if needed. Progress of labor will be closely monitored using a partograph, and the duration of different stages of labor will be recorded by trained staff unaware of the treatment given.
All participants will be monitored during labor and for 24 hours after delivery to ensure safety. The results will help determine whether dexamethasone is an effective and safe option to improve labor outcomes in women with PROM at term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | Intravenous dexamethasone |
|
| Normal Saline | Placebo Comparator | Intravenous Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 8 mg (2 ml) intravenous dexamethasone sodium phosphate will be given one hour before initiation of labor induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction-delivery time | Time in hours from PGE1 vaginal placement to delivery of the fetus | From enrollment till fetus delivery, within 24-hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syeda A Professor, FCPS | Nishtar Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Medical University | Multan | Punjab Province | 60000 | Pakistan |
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| Prostaglandin E1 | Drug | 25 µg vaginal prostaglandin E1 will be used to induce labor |
|
|
| Normal Saline | Drug | 2 ml intravenous normal saline will be given as placebo, will be given one hour before initiation of labor induction |
|
| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000527 | Alprostadil |
| D016595 | Misoprostol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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