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Randomised, double-blinded placebo controlled trial of the use of tocolysis for a repeat external cephalic version after a failed version for breech presentation at term

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31614268
Enrollment
124
Registered
2004-01-23
Start date
2000-04-06
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Pregnancy and Childbirth Other assisted single delivery

Interventions

1. 50 mg ritodrine hydrochloride infusion 2. 17 ml dextrose saline solution infusion

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women with suspected or confirmed breech presentation at >36 weeks gestation 2. Have undergone a single (<15 mins) unsuccessful attempt at external cephalic version without tocolysis at 37 or more weeks' gestation

Exclusion criteria

Exclusion criteria: 1. Abnormal cardiotocograph 2. Cardiac disease 3. Pre-existing or gestational diabetes 4. Hypertension; 5. Pre-existing indication for caesarian section 6. Suspected unstable lie 7. Pre-eclampsia 8. recent (<4 weeks) antepartum haemorrhage 9. suspected fetal compromise 10. rhesus immunisation

Design outcomes

Primary

MeasureTime frame
1. Incidence of cephalic presentation at delivery 2. Subjective patient assessment of discomfort 3. Incidence of caesarian section 4. Length of hospital stay 5. Incidence of neonatal Apgar scores <7 at 5 minutes 6. Incidence of neonatal intensive care admission

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026