The objective of this study is to determine whether retention of cerclage after PPROM reduces chorioamnionitis, improves latency (without a significant increase in chorioamnionitis), and lessens neonatal morbidity.
ID
Bron
Verkorte titel
Aandoening
Premature Preterm Rupture Of Membranes, removal versus retention of cerclage.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To determine whether retention of cerclage after PPROM improves in terms of:<br>
1. Chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);<br>
2. Latency (the interval from membrane rupture to the onset of labor in days) without a significant increase in chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);<br>
3. Composite Neonatal Outcome:<br>
A. Fetal or neonatal death;<br>
B. Respiratory distress syndrome;<br>
C. Documented sepsis within 72 hours of delivery;<br>
D. Grade 3 or 4 intraventricular hemorrhage;<br>
E. Stage 2 or 3 necrotizing enterocolitis.
Achtergrond van het onderzoek
Rationale:
The question of whether to remove cerclage after preterm premature rupture of membranes (PPROM) is one of the unresolved controversies in obstetrics. It is unclear whether latency (the interval from membrane rupture to the onset of labor) is prolonged with retention of the suture. Furthermore, some studies suggest an increase in major infectious maternal morbidity and possibly neonatal morbidity.
Objective:
The objective of this study is to determine whether retention of cerclage after PPROM reduces chorioamnionitis, 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.
Study population:
Women with PPROM and cerclage between 22+0/7 – 32+6/7 weeks gestational age.
Intervention:
Random allocation to retention of cerclage or immediate removal of cerclage.
Main study parameters/endpoints:
Latency, chorioamnionitis as defined by temp > 38°C plus fetal tachycardia or uterine tenderness, Composite Neonatal Outcome, NICU stay, birth weight, estimated gestational age at delivery, postpartum endometritis and maternal sepsis.
Doel van het onderzoek
The objective of this study is to determine whether retention of cerclage after PPROM reduces chorioamnionitis, improves latency (without a significant increase in chorioamnionitis), and lessens neonatal morbidity.
Onderzoeksopzet
In view of the relatively small sample size, the fact that both treatments are already applied and are both mentioned in the Dutch guidelines, an interim analysis is not planned.
Onderzoeksproduct en/of interventie
Random allocation to retention of cerclage or immediate removal of cerclage.
Publiek
Dept Obstetrics and Gynaecology
T.S. Lange, de
Amsterdam
The Netherlands
apostel4@studies-obsgyn.nl
Wetenschappelijk
Dept Obstetrics and Gynaecology
T.S. Lange, de
Amsterdam
The Netherlands
apostel4@studies-obsgyn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. A previously placed prophylactic cerclage defined as any cerclage done ≤ 23+6/7 weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation ≤ 3 cm;
2. Spontaneous rupture of membranes 22+0/7 ¨C 32+6/7 weeks;
3. Singleton or twin gestation;
4. Shirodkar or McDonald cerclage in place ≥ 1 week.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Active labor (>8 uterine contractions per hour);
2. Chorioamnionitis as defined by temp > 38oC plus fetal tachycardia or uterine tenderness;
3. Placenta previa or undiagnosed vaginal bleeding;
4. Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP);
5. Presentation > 48 hours after rupture of membranes;
6. Abdominal cerclage;
7. Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm);
8. Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3469 |
| NTR-old | NTR3621 |
| CCMO | NL36460.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38330 |