Early Amniotomy, Unfavorable Cervix
Conditions
Brief summary
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.
Detailed description
During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).
Interventions
DRUGPGE2
10 mg PGE2 vaginal ovul(Propess)
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. intact membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had obstetrical indications for induction of labor, 7. had less than three uterine contractions in every 10 minutes.
Exclusion criteria
1. Patients who have contraindications for vaginal delivery, 2. previous uterine surgery, 3. fetal malpresentation, 4. multifetal pregnancy, 5. more than three contractions in 10 minutes, 6. contraindications to prostaglandins, 7. a category II or III fetal heart rate pattern, 8. anomalous fetus, 9. fetal demise 10. women with immediate delivery indications -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| induction-to- delivery time | delivery (the length of time between the beginning of induction and the end of labor) |
Secondary
| Measure | Time frame |
|---|---|
| mode of labor (vaginal or C-section) | delivery |
| successful induction | vaginal delivery within 24 h from the beginning of induction |
Countries
Turkey (Türkiye)
Outcome results
None listed