Cervix; Pregnancy Clinical Trial
Official title:
Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour
To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 30, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 39 Years |
Eligibility | Inclusion Criteria: - Gestational age36:41 weeks. - Singleton pregnancy. - Absence of labour pain. - Living fetus with cephalic presentation. - Fetal weight < 4 k.gs. - No previous uterine surgical procedures. - No liquor abnormalities. - Bishop score < 5. Exclusion Criteria: - - Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus. - Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress. - Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress. - Fetal weight > 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia . - Previous uterine surgery.contraindication of labor induction for fear of rupture uterus. - Asthmatic patient or women with allergy to prostaglandins or steroidal. - Non-vertex presentation.contraindication of labor induction as it may cause rupture uterus. - Fetal or maternal complications that might cause cesarean section. - Intrauterine fetal death.often induction of labor in women with a dead fetus is performed before term when the uterus may be less responsive to uterotonics than it is at term and this will affect the results of the study |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Induction of labour with closed cervix | assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process. | from 0 hours to 14 hours after induction of labour | |
Secondary | The Whole Delivery time after induction of labour. | The whole time from induction to the end of vaginal labour with complications that may arise as:
-uterine hyperstimulation, postpartum hemorrhage, rupture of the uterus and neonatal morbidity, fetal distress, and fetal hypoxia. |
from 0 hours to the end of the delivery |
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