Induction of Labour
Conditions
Interventions
Trade Name: propess
Product Name: propess
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: DINOPROSTONE
Other descriptive name: PROSTIN E2
Concentration unit: mg milligram(s)
Concentr
Sponsors
St George's University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 years or over with a single fetus and uncomplicated pregnancy, who were at a Gestational age > 37 completed weeks, needing induction of labour. 2. No medical risk factors. 3. Able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Unsuitable for outpatient management 2. Unsuitable for randomisation to either PGE2 (e.g. previous Caesarean section/hypersensitivity to Prostaglandins) or catheter use (e.g. latex allergy), or prior attempted IOL in this pregnancy. 3. Had ruptured membranes, or evidence of regular uterine contractions at time of booked induction. 4. Multiple pregnancy or non-vertex presentation; 5. Placenta praevia. 6. Lethal fetal congenital anomaly. 7. Non-vertex presentation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a feasibility study. The primary objective is to determine the feasibility of conducting a randomised controlled trial of Prostaglandin pessary versus trans-cervical balloon catheter for out-patient induction of labour. ;Secondary Objective: The secondary aim is to assess women’s experience with these methods and their preference and to assess the clinical efficacy, cost effectiveness and safety of trans-cervical balloon catheter compared to Prostaglandins for out-patient induction of labour in low-risk women. Logistic issues of Propess and balloon catheter induction, and possible problems with them would come to light only after a feasibility trial has been conducted. Data will also be gathered on clinical outcomes including mode of birth, rate of labour and birth complications, admissions to NNU, maternal and infant morbidity and on women's experiences of induction using the different methods.;Primary end point(s): Number of eligible women willing to be randomised to Propess or balloon catheter in an outpatient setting.;Timepoint(s) of evaluation of this end point: End of 12 month Recruitment period | — |
Countries
United Kingdom
Outcome results
None listed