Induction of Labor Affected Fetus / Newborn Clinical Trial
Official title:
Dexamethasone Effect on Induction Delivery Interval at Term Randomized Controlled Trial
NCT number | NCT03658590 |
Other study ID # | 100 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | June 30, 2018 |
Verified date | September 2018 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the effect of intravenous injection of a single dose of dexamethasone in shortening the duration interval between initiation of labor induction and delivery of the fetus in primigravida full-term pregnancy.
Status | Completed |
Enrollment | 102 |
Est. completion date | June 30, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Primiparity - Singleton pregnancy - Gestational age i.e. 40 weeks or more by date or 1sttrimestric ultrasound. - Bishop score of 4 or greater. - Longitudinal lie. - Vertex presentation. - Intact membranes Exclusion Criteria: - Refused consent - Malpresentation. - Multiple pregnancies. - Active phase of labour. - Rupture of membranes (ROM). - Cephalo-pelvic disproportion. - Previous C-section or myomectomy operation. - Known contraindication or hypersensitivity to Dexamethasone. - Fetal distress. - IUFD - Current maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension. - Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound. - Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
samar sayed el sayed |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The interval between the initiation of induction and the delivery of the fetus. | Mean time of interval between the initiation of induction and the delivery of the fetus in the two groups. | Up to 1 day | |
Secondary | The duration of the first stage of labor (Partographic representation will do for each participant). | Mean time of duration of the first stage of labor in the two groups. | Up to 1 hour | |
Secondary | The duration of the second stage of labor. | Mean time of duration of the second stage of labor in the two groups. | Up to 2 hours | |
Secondary | The duration of the third stage of labor. | Mean time of duration of the third stage of labor in the two groups. | Up to 30 minutes | |
Secondary | The neonatal outcome by APGAR score. | Mean of APGAR score at 1 and 5 minutes for fetus in the two groups. | at 1 and 5 minutes | |
Secondary | Any postpartum maternal adverse effects (e.g. vital sing abnormality, any maternal postpartum hemorrhage and central nervous system manifestation). | Percentage of postpartum adverse effects in both group. | Up to 1 day |
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