An interventional study of Oxytocin in Fetal Infection, Chorioamnionitis and Endometritis, sponsored by Rambam Health Care Campus. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.
PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.
In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's planned enrollment of 524 is above the median of 157 across 22 interventional studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
Drug: Oxytocin
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.
Drug: Oxytocin
The drug wil be adminisrate for augmentation of labor at admission.
Also known as: pitocin
Maternal infectious morbidity
Maternal chorioamnionitis and/ or endometritis
Time frame: Up to 48 hours postpartum
Length of latent and active phases of labor.
According to vaginal examinations during labor
Time frame: During Labor
Adverse maternal outcome
infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).
Time frame: Up to 48 hours postpartum
Adverse neonatal outcome
stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score \< 7, umbilical artery pH \< 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.
Time frame: Up to 48 hours postpartum
Plan to share: No
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Studies of the drug tested here: Oxytocin