A randomized intervention trial on the effect of a lay doula in the Dutch obstetric system: a Pilot Study
Go to the Doula study website
The Dutch system of obstetric health care, with its special position of the uncomplicated birth based on a primary and a secondary care chain, is at present vulnerable. The percentage of referrals from primary to secondary care with the indication non progressing dilatation or required pain medication did increase over the last 10 years. At the same time the amount of interventions in secondary obstetric care has also increased: the number of caesareans, instrumental deliveries and need for pain medication. In other countries, continuous support during labour by a trained labour coach, the so-called doula, next to the medical care giver, has proved to be very effective to reduce complications, medical interventions en psychological trauma during labour. The short trained lay doula has also proven to be effective in increasing quality of life, and seems to be effective to prevent labour complications and to shorten the length of labour. Looking at the extraordinary character of the Dutch Obstetric Care system, it is imperative to investigate the effect of a lay doula in a randomised trial in the Dutch setting. One group of women will deliver with a lay doula at her site during labour; the other group of women will deliver with support during labour as usual given in the Dutch system. Besides the primary outcome, the percentage of referrals from primary to secondary care due to no progress of dilation, no progress of labour or required pain medication, there will be a questionnaire to investigate the preference, quality of life and wellbeing of the mothers and their partners.
In conclusion this study investigates if continuous support by lay doula of women in labour results in better health outcomes of mother, partner and child.
Multicentre randomised controlled trial.
100 Nulliparous women carrying a singleton low risk pregnancy at the time of enrollment and who are able to identify a female friend or family member willing to act as a lay doula.
Support by a lay doula versus usual care as practiced in the Netherlands.
The doula group will be trained traditional doula supportive techniques in two 3 hour sessions.
The intervention group is called A, the controlled group B.
At group A the pregnant woman will be asked to identify a lay doula so a girlfriend, sister or mother to participate with her at a 2 x 3 hours training given by a professional doula trainer. The girlfriend, sister or mother is called ‘lay doula’. This lay doula will support the pregnant woman and her partner during labour continuously.
Group B will have ‘usual care’: the woman in labour will be visited and supported as usual during labour by her midwife, gynaecologist or nurse (or kraamzorg) and of course her partner.
Primary outcome measures:
1. The percentage of referrals from primary to secondary care with no progress of dilation or required pain medication.
2. Length of labour, type of delivery, type and timing of analgesia/anesthesia, and Apgar scores.
As secondary measure the Quality of life will be assessed by validated questionnaires. Each woman and her partner will complete a questionnaire addressing health related quality of life; i.e. HADS and WDQ (Wijma Delivery Expectancy/Experience Questionnaire) .
These questionnaires will be filled in directly after randomisation (at 28-34 weeks gestational age) and 6 weeks postpartum
The analysis will be done based on intention to treat. Relative risks and 95% confidence intervals will be calculated for the relevant outcome measures. Quality of life will be analysed using repeated measures analysis of variance.
The aim of the economic evaluation is to compare the costs and health effects of (A) labour with a lay doula (experimental strategy) versus (B) expectant normal birth care.
We will calculate costs of initial and additional treatment, admission to home care or hospital, mode of delivery and costs of hospitalization of mother and child in the first 6 weeks after delivery. As we expect a reduction of interventions in labour in the intervention group, the economic analysis will be a cost-effectiveness analysis based on the Dutch DBC system and primary obstetric care charges.
Total study time 10 months, preparation one month, inclusion of women during 3 months, data collecting and analysis and reporting during 4 months.
K.M.W. Bloemenkamp PhD, MD, LUMC Leiden
J.C. Droog, midwife, LUMC Leiden