Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.
Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable
study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early amniotomy | Active Comparator | Group A:
|
|
| Late amniotomy | Active Comparator | Group B:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | rupture of membrane early and late |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful induction | definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction | immediately after intervention |
| induction-delivery interval | duration of labor and amniotomy delivery interval | immediately after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| misoprostol doses administered | number of misoprostol doses administered | during the intervention |
| the need for augmentation of labor | the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Nulliparous Women
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University hospital | Shibīn al Kawm | Menoufia | 11111 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D000074885 | Amniotomy |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
Not provided
Not provided
Not provided
Not provided
| during the intervention |
| intrapartum meconium | intrapartum meconium passage | during the intervention |
| Apgar score | Apgar score less than 7 at 1 and 5 minutes | during the intervention |
| newborn admission in the neonatal intensive care unit | newborn admission in the neonatal intensive care unit (NICU). | immediately after intervention |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D007751 | Labor, Induced |
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |