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New treatment option for Preterm PROM (Pregnancy)
Official title Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
ClinicalTrials.gov ID: NCT07119398
What this study is testing
What is Oxytocin plus Foley Catheter?
Oxytocin plus Foley Catheter is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for preterm prom (pregnancy).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking. Studies have shown no difference between oxytocin and misoprostol use for labor induction in this cohort (1).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Patients 18-50 years of age;
- The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
- PPROM;
- Cervical dilation \</= 2cm
- Fetal cephalic presentation;
You likely can't join if
- Spontaneous labor
- Known allergy to latex;
- Cervical dilation \>2cm;
- Chorioamnionitis;
- Contraindications to induction of labor or use of Foley for cervical ripening
- Known or suspected fetal anomaly or aneuploidy;
See the full eligibility criteria
- Patients 18-50 years of age;
- The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
- PPROM;
- Cervical dilation \</= 2cm
- Fetal cephalic presentation;
- The patient is between 34 weeks 0 days and 36 weeks 6 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the...
- Spontaneous labor
- Known allergy to latex;
- Cervical dilation \>2cm;
- Chorioamnionitis;
- Contraindications to induction of labor or use of Foley for cervical ripening
- Known or suspected fetal anomaly or aneuploidy;
- Prisoners.
The study team makes the final eligibility decision.
Where it's taking place
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.