Induction of Labour to terminate pregnancy after third trimester with specific indications in Obstetrics practice Pregnancy and Childbirth
Conditions
Interventions
Based on computer-generated block randomization, eligible patients will be allocated 1:1 to the standard treatment group or to the low dose oral misoprostol intervention group. Allocated treatments wi
Sponsors
Papua New Guinea Institute of Medical Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Able to complete study informed consent procedures, to understand the benefits of the study and the potential risks and benefits associated with study participation 2. Aged between 18 and 44 years 3. Willing to undergo clinical assessment, including cervical assessments to establish the Bishop score (cervical readiness or softness and dilatation). 4. Willing to come back after four weeks for follow up progress and check up. 5. Third trimester singleton pregnancies in women over 18 years old 6. Bishops score of less than 6 7. Cephalic presentation 8. Hemoglobin concentration of more than 8g/dL
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancies confirmed with ultrasound examination 2. Previous caesarian sections or other conditions that required surgery on the uterus with uterine scar 3. Chronic illness such as TB, renal failure, other malignancies and heart disease 4. Hemoglobin of less than 8g/dL with symptomatic anemia 5. Unstable or abnormal lie with malpresentation 6. Any high risk cases that require immediate caesarian sections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women who have a successful live vaginal delivery without any severe adverse events is determined by monitoring and caring for the mother and baby until delivery is achieved with no complications leading to perinatal and maternal mortality and morbidity during the course of the study. Adverse events include: 1. Failed induction necessitating cesarean section 2. Maternal death 3. Retained placenta 4. Perinatal death 5. Neonatal admission to special care nursery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of successful live births delivered vaginally within 24 hours is measured by the number of deliveries born without complications or severe adverse events from a total of those induced in both the treatment and intervention arms 2. Proportion of mothers requiring Foley’s catheterization is measured by the number of women who did not progress to vaginal delivery with the use of misoprostol and were subjected to Foleys catheterization, compared to those that were successfully induced. This proportion will be taken from the number using Foleys Catheter over the total that was induced 3. Proportion of mothers requiring oxytocin augmentation is measured by the number of study patients who are having prolonged labour and therefore clinically assessed to require assistance with intravenous oxytocin that subsequently results in delivery of the baby. This proportion will be taken from the number augmented with intravenous oxytocin over the total that was induced 4. Neonatal Apgar scores =7 at 5 minutes post-delivery is measured by the Apgar Scoring System which takes into consideration the appearance of the baby, the color of the newborn baby, the pulse of the baby, grimacing of the face and respiration rate at the time of delivery to 5 minutes 5. Maternal and neonatal adverse events will be investigated by interviewing the patient using standard case reporting forms and doing clinical examinations on both the baby and the mother to determine if they have any complication related to the trial during the peripartum period as well as at 4 weeks post-discharge | — |
Countries
Papua New Guinea
Outcome results
None listed