The objective of this study is to determine whether retention of cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Latency
Chorioamnionitis as defined by temp > 38°C plus fetal tachycardia or uterine
tenderness
Composite Neonatal Outcome * any one of the following (for twins, either
infant) :
Fetal or neonatal death
Respiratory distress syndrome
Documented sepsis within 72 hours of delivery
Grade 3 or 4 intraventricular hemorrhage
Stage 2 or 3 necrotizing enterocolitis
Secondary outcome
NICU stay
Birth weight
EGA at delivery
Postpartum endometritis
Maternal sepsis
Background summary
The placement of cervical cerclage is standard of care for women who experience
incompetent cervix. Treadwell et al, published the largest retrospective
review of 482 patients receiving cerclage (364 elective and 118 emergent).
They found premature rupture of membranes (PROM) in 38% of the subjects with 9%
delivering <27 weeks. Preterm birth is the cause of at least 75% of neonatal
deaths that are not due to congenital malformations. The question of whether
to remove cerclage after preterm premature rupture of membranes (PPROM) is one
of the unresolved controversies in obstetrics because the few available studies
are retrospective, all have small numbers of patients, and the studies have
given conflicting results regarding the safety of retaining a cerclage after
preterm premature rupture of the membranes. It is unclear from the
retrospective studies whether latency (the interval from membrane rupture to
the onset of labor) is prolonged with retention of the suture. Furthermore,
some, but not all studies suggest an increase in major infectious maternal
morbidity and possibly neonatal morbidity.
Study objective
The objective of this study is to determine whether retention of cerclage after
PPROM improves latency (without a significant increase in chorioamnionitis) and
lessens neonatal morbidity.
Study design
Randomized trial performed in all ten perinatal centers in The Netherlands.
Intervention
Retention of cerclage.
Study burden and risks
As we compare two strategies that are already applied in current practice, no
specific risks or burden are expected from the study.
The potential benefit of retention of cerclage would be a longer duration of
the pregnancy, and therefore a better development of the child. The potential
harm would be the complications of retention of cerclage, of which intrauterine
infection will be the most obvious one. At present, there is no evidence on
which a rational choice between the two strategies can be based.
Meibergdreef 15
Amsterdam 1105 AZ
NL
Meibergdreef 15
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
A previously placed prophylactic cerclage defined as any cerclage done * 23w6d weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation * 3 cm
Spontaneous rupture of membranes 22w0d-32w6d weeks
Singleton or twin gestation
Shirodkar or McDonald cerclage in place * 1 week
Exclusion criteria
Active labor (>8 UCs per hour)
Chorioamnionitis - defined by temp of >38ºC, plus fetal tachycardia or uterine tenderness
Placenta previa or undiagnosed vaginal bleeding
Nonreassuring fetal status by NST or BPP
Mature pulmonary studies
+ gram stain, culture, WBC * 30, or glucose * 14 on amniocentesis (amniocentesis optional)
Major fetal anomaly
Presentation > 48 hours after rupture of membranes
Abdominal cerclage
Cerclage done for symptomatic cervical dilation (cervix dilated > 3cm)
Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)
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 | NL36460.018.12 |