To compare the safety and efficacy of 'low dose' vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term

ISRCTN	ISRCTN85744560
DOI	https://doi.org/10.1186/ISRCTN85744560
Protocol serial number	N0533091848
Sponsor	Department of Health (UK)
Funder	Queen Mary's Sidcup NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Sarah Gregson
Scientific

Maternity Unit
Queen Mary's Sidcup NHS Trust
Frognal Avenue
Sidcup, Kent
DA14 6LT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A single-blind randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term
Study objectives	To determine if vaginal misoprostol is a better method of inducing labour at term than dinoprostone vaginal gel.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Induction of labour
Intervention	1. Misoprostol 2. Dinoprostone
Intervention type	Other
Primary outcome measure(s)	1. Uterine tachysystole 2. Hyperstimulation 3. Presence of meconium in the amniotic fluid 4. Apgar Scores at 5 min. Umbilical arterial pH and base deficit 5. Neonatal Unit admission 6. Induction - delivery interval 7. Method of delivery 8. Bishop score at onset of labour 9. Oxytocin requirements in labour 10. Mode of delivery 11. Analgesia requirements in labour
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key inclusion criteria	1. Women at term (37-42 completed weeks of pregnancy) 2. Single fetus, cephalic presentation 3. Membranes may be intact or ruptured 4. Reactive fetal heart tracing
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/2000
Date of final enrolment	31/01/2004

Maternity Unit

Sidcup, Kent
DA14 6LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes