Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric oxide donor in addition to dinoprostone for induction of cervical ripening in the third trimester through progression in the Bishop's score during 24 hour period.
Detailed description
Objectives: The primary outcome of the study is to compare the changes occurring to the cervix through the progression in the Bishop's score between NO donor (nitroglycerine patch) vs placebo; in combination with a well-established method of induction (Dinoprostone). The secondary objective of the study is to observe and report possible fetal and maternal side effects that may be associated. This will establish the safety and tolerability of NO donors. Research Question: Does the usage of Nitroglycerine skin patch enhance cervical ripening and facilitate induction of labor by Dinoprostone? Null hypothesis: Nitroglycerine skin patch does not cause advantage for ripening of the cervix nor facilitate the process of labor induction. Alternative hypothesis : Nitroglycerine skin patch has favorable effect in enhancing cervical ripening and the outcome of induction of labor.
Interventions
DRUGNitroderm TTS
Transdermal nitroglycerin 5mg skin patch
DRUGDinoprostone
Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
Sponsors
Dr. Ahmed S. Abd El-Hameed
Prof. Abdel-Megeeed I. Abdel- Megeeed
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Singleton living full-term fetus. 2. Cephalic presentation, 3. Bishop score less than 5, 4. Assuring fetal monitoring, 5. The mother does not have PROM,
Exclusion criteria
1. Expected fetal anomaly (eg. by ultrasound), 2. Abnormal presentation, 3. Multiple pregnancy, 4. Non assuring fetal CTG, 5. Fetus more than 90th percentile of expected weight, 6. Previous maternal obstructed labor or previous cesarean section, 7. Maternal obstetric or medical complication, 8. Structural anomaly of the uterus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the cervical Bishop's score | 6,12,18 and 24 hours after administration | progression of Bishop's score recorded twice during the induction of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of any fetal or maternal side effects | From the time of administration of medication, cases will be assessed every 6 hours till 24 hours after delivery at time of discharge | associated headache and nausea (for instance) are well-recognized side effects during the induction of labor |
| Need of Oxytocin to initiate uterine contractions | from time of patch administration up to 24 hours | Whether the case managed to initiate uterine contractions without the need to induce them with oxytocin |
Countries
Egypt
Outcome results
None listed