To evaluate the effectiveness of tocolytic maintenance therapy for postponing delivery after initial 48-hour tocolytic therapy in women with threatened preterm birth from 24-32 weeks gestational age.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure will be a composite neonatal morbidity status,
including perinatal death, chronic lung disease (CLD) and severe respiratory
distress syndrome (IRDS), intra ventricular hemorrhage (IVH) grade 3 and 4,
periventricular leukomalacia (PVL) and necrotizing enterocolitis (NEC) at the
calculated term date.
Secondary outcome
Secondary outcomes will be gestational age at delivery, number of days in NICU,
and total days in hospital and costs.
Background summary
In the Netherlands, preterm birth is responsible for over 80% of all neonatal
deaths and 50% of childhood neurological morbidity. Approximately 1800 children
are born after a pregnancy of 24-32 weeks; about 75% of them as a result of
spontaneous labour. Women with threatened preterm labour between 24 and 32
weeks are treated with tocolytics and steroids for 48 hours. After this period
of time, 75% of these women remain undelivered, but they remain at risk for
going into labour prematurely. At present, it is not clear if prolonged
tocolytic treatment is effective in postponing delivery and, if so, whether the
effects justify the additional costs of this treatment.
Study objective
To evaluate the effectiveness of tocolytic maintenance therapy for postponing
delivery after initial 48-hour tocolytic therapy in women with threatened
preterm birth from 24-32 weeks gestational age.
Study design
Randomized double-blind placebo-controlled trial performed in all ten perinatal
centres in The Netherlands.
Intervention
Prior to randomization, all patients will undergo measurement of cervical
length and, in case of unruptured membranes, measurement of cervical
fibronectin and vaginal examination. All women will then be randomly allocated
to receive either the calcium antagonist nifedipine (intervention group) or
placebo (control group) for a period of 12 days.
Study burden and risks
Participation in the study will not lay an extra burden on the patients. This
treatment is used in practice these days, but the effectivity is uncertain.
There is a small risk of hypotension as a result of the medication. A possible
benefit for the patient is that if tocolysis proves to be effective, perinatal
outcome for patients on active study medication will be better.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Women with a gestational age between 24+0 and 31+6 weeks who are spontaneously in labour, and who have been treated for 48 hours with tocolytics.
Exclusion criteria
Women with signs of intra-uterine infection, women whose child has signs of fetal distress (abnormal CTG or biophysical profile) or major congenital malformation and women with any contraindication for the use of nifedipine or having a maternal disease (severe hypertension, HELLP syndrome, preeclampsia or other) or other reason for delivery.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-003900-36-NL |
| CCMO | NL18675.018.07 |