Looking at the extraordinary character of the Dutch Obstetric Care system, it is specific relevant 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…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures:
• The percentage of referrals from primary to secondary care with no progress
of dilation or required pain medication.
• Length of labor, type of delivery, type and timing of analgesia/anesthesia,
and Apgar scores.
Secondary outcome
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 HADS and WDQ (Wijma Delivery
Expectancy/Experience Questionnaire) [6].
These questionnaires will be filled in directly after randomisation (at 28-34
weeks gestational age) and 6 weeks postpartum
Background summary
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 labor by a trained labor 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 labor.
The short trained lay doula has also proven to be effective in increasing
quality of life, and seems to be effective to prevent labor complications and
to shorten the length of labor.
Study objective
Looking at the extraordinary character of the Dutch Obstetric Care system, it
is specific relevant 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 labor; the other group of women will deliver with support
during labor as usual given in the Dutch system.
Study design
Randomised controlled trial (pilot)
Intervention
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 2x4 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 labor continuously.
Group B will have *usual care*: the woman in labor will be visited and
supported as usual during labor by her midwife, gynaecologist or nurse (or
kraamzorg) and of course her partner.
Study burden and risks
Benefit: less referrals to secondary care i.e. less interventions such as
epidural, artificial deliveries and caesarian section
Albinusdreef 2
Leiden
Nederland
Albinusdreef 2
Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
• Nulliparous women who are able to identify a woman (friend or family member) who is willing to be lay doula.
• Maternal age > 18 years
• Signed informed consent
Exclusion criteria
Multiparous, twin pregnancies, antenatal care by obstetrician
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22960.058.08 |