Cervical Ripening and Induction of Labor
Conditions
Brief summary
The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.
Detailed description
This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.
Interventions
DEVICEFoley's Catheter
intracervical extraamniotic Foley's catheter
DRUGprostaglandin E1 analogue
intravaginal misoprostol
Sponsors
Nwali Matthew Igwe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Parturients who gave consent * has low bishop score (≤5) * term singleton cephalic presenting fetus * intact membranes * no contraindication to vaginal delivery
Exclusion criteria
* those who refused consent * preterm delivery * vaginal infection * non-cephalic presentation * multiple gestation * low lying placenta/previa, * vaginal bleeding, * previous cesarean section * rupture of membranes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bishop Score of 6 or more | 24 hours |
Countries
Nigeria
Outcome results
None listed