Using Misoprostol to treat suspected retained products after childbirth
MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTION - A RANDOMIZED TRIAL
This study tests if the medication Misoprostol can help new mothers who might have leftover tissue after childbirth, reducing the need for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Assuta Ashdod Hospital Academic / other |
| Locations | 1 site (Ashdod) |
| Trial ID | NCT06009679 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Misoprostol in treating postpartum patients who are suspected to have retained products of conception (RPOC). It compares the outcomes of patients receiving Misoprostol to a control group managed expectantly. The goal is to determine if Misoprostol can reduce the need for surgical interventions in these patients. The study is conducted as a prospective randomized trial at Assuta Ashdod University Hospital.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 who have had a spontaneous vaginal delivery or vacuum extraction and are at risk for RPOC.
Not a fit: Patients who had a cesarean section during their index pregnancy or those without risk factors for RPOC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce the need for surgical procedures in postpartum patients with suspected RPOC.
How similar studies have performed: Previous studies have shown that Misoprostol is effective for various obstetric indications, but its specific use for postpartum RPOC is less well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between the ages of 18 years - 45 years. * Spontaneous vaginal delivery or vacuum extraction, including VBAC cases * Revision of the uterine cavity or manual lysis of the placenta postpartum * Early postpartum hemorrhage * Cases with a history of treated postpartum residua (by curettage or hysteroscopy) * Placental pathology (succenturiate placenta, bilobed placenta) * Pregnancy that started as a multifetal gestation with only one fetus reached advanced pregnancy * Bumm curettage post-delivery * Patients are able to provide written consent Exclusion Criteria: * Patients with no risk factors of RPOC * Cesarean section on index pregnancy * Cases requiring urgent curettage for late postpartum hemorrhage * Inability to consent due to cognitive or language barrier
Where this trial is running
Ashdod
- Assuta Ashdod University Hospital — Ashdod, Israel (Recruiting)
Study contacts
- Study coordinator: oshri Barel, MD
- Email: oshrib@assuta.co.il
- Phone: +972559382117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.