ECV with tocolysis

Management of breech presentation: external cephalicversion with tocolysis: a multi-centre randomised controlled trial

April 2008, first results: The ECV Tocolysis trial ruled out a large improvement of the effectiveness of external cephalic version due to nifedipine. Abstract ECV tocolysis april 2008 (Pdf).

Research question
For women with a singleton at term fetus in breech presentation, what is the successrate of external cephalic version (ECV) with a calcium antagonist nifedipine compared toversion without medication?

Background
Breech presentation occurs in 3-4 % of the at term pregnancies. Breech presentationis associated with higher neonatal mortality and morbidity compared to cephalic presentation.One reason is the higher incidence of congenital anomalies for the breech presenting fetus,breech delivery is also associated with higher short-term neonatal morbidity and mortality. Alarge multicentre RCT was published two years ago. According to this trial the fetus isbetter off with a primary caesarean section in terms of morbidity and mortality. Therefore,after this trial the number of caesarean sections (CS) on breech presentation is rising. Thenational CS rate has risen from 45% to 85%. Consequences of a higher CS rate: increasedmaternal morbidity, longer hospital admission and future consequences for the nextpregnancy (hospital delivery and probably higher perinatal morbidity and mortality due touterus rupture).
ECV without tocolysis after 36 weeks of gestation can reduce the breech presentationby 41%. ECV with tocolysis is more successful and has a success rate of 57%. Currentlyused tocolytics have maternal cardiovascular side-effects in terms of flushing and palpitationsand therefore seldom used in clinical practice. A new tocolytic nifedipine, a calciumantagonist exists wich has significant less side effects.

Study design
The proposed research is a multi-centre randomised double-blinded placebo controlledtrial of ECV with tocolysis. This is an effectiveness trial that will be carried out by physiciansand midwives who have experience in the ECV manoeuvre.

Selection criteria
Inclusion criteria: live singleton at term fetus in breech presentation. Exclusioncriteria: 1. contraindications to labour or vaginal birth, 2. any contraindication to ECV, 3.contra-indications for nifedipine.

Randomisation
Women who meet the eligibility criteria will be randomly assigned to two categories:version with nifedipine or version with a placebo with stratification by centre and parity.Randomisation will be controlled by the pharmacy of the AMC.

Outcome
The primary outcome is the number of cephalic presentations at birth in each category.Secondary outcomes include: 1. caesarean section rate, 2. fetal complications, 3. maternalcomplications.

Sample size
To be able to show a difference of 17 % between the two tocolytics with a power of80% we will need 146 participants in each arm. So the total sample size is 292.

Projectleaders
Dr. J.A.M.van der Post, gynaecologist, AMC Amsterdam
Dr. B.W. Mol, gynaecologist, AMC Amsterdam
Drs. B. Opmeer, AMC Amsterdam
Drs. M. Kok, AMC Amsterdam

Participating hospitals
Alkmaar - Medisch Centrum Alkmaar
Almere - Flevoziekenhuis
Amsterdam - Academisch Medisch Centrum
Amsterdam - Onze Lieve Vrouwe Gasthuis
Breda - Amphia ziekenhuis
Hoofddorp - Spaarne ziekenhuis
Zaandam - Zaans Medisch Centrum

Contact
Drs. M. Kok Academisch Medisch Centrum
Dept. Obstetry & Gynaecology, H4-205
Meibergdreef 9
1105AZ Amsterdam
mkok@amc.uva.nl

Downloads
ECV tocolysis protocol (Pdf)