MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTION

NCT06009679 | Unknown

• 1 other identifier: 000621AAA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this current study is to evaluate the efficacy of treatment of postpartum patients with suspected retained products of conception (RPOC) with Misoprostol in reducing the frequency of postpartum RPOC compared to a control group of patients that will be managed expectantly, in a prospective randomized trial.

Conditions

Retained Products of Conception

Outcome Measures

Primary Outcomes (1)

• Cases of retained products of conception

  The primary endpoint will be the number of patients with histopathology-proven retained products of conception at 8-16 weeks postpartum in each group.

  8-16 weeks postpartum

Secondary Outcomes (6)

• Need for hysteroscopy due to suspected RPOC

  8-16 weeks postpartum

• side effects of treatment

  8-16 weeks postpartum

• Late postpartum hemorrhage

  6 weeks postpartum

• Blood transfusions

  6-18 weeks postpartum

• endomyometritis / PID

  6-18 weeks postpartum

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will include patients with suspected postpartum RPOC that will receive treatment with Misoprostol, 600 microgram SL/PO/PV

Drug: Misoprostol 200mcg Tab

Control group

NO INTERVENTION

The control group will include women with suspected postpartum RPOC per ultrasound examination that will undergo conservative follow-up with ultrasound for a period of 6-12 weeks postpartum

Interventions

Misoprostol 200mcg Tab DRUG

Patients in the intervention group with suspected postpartum RPOC will receive 600 micrograms of misoprostol up to 3 times following delivery and followed up by ultrasound and clinical examinations for 6-12 weeks post-partum

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

oshri Barel, MD

CONTACT

+972559382117; oshrib@assuta.co.il

Irad Burshtein, MD

CONTACT

+972537345127; iradb@assuta.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR OSHRI BAREL

Model Details: Two arms: the intervention groups will include patients with suspected postpartum RPOC that will receive treatment with Misoprostol, and the control group will undergo conservative follow-up with ultrasound. The primary endpoint will be the number of patients with histopathology-proven retained products of conception at 8-16 weeks postpartum in each group. secondary endpoints will be the number of hysteroscopies in each group, side effects of treatment, late postpartum hemorrhage, blood transfusion, endomyometritis / PID and re-admissions to the hospital in each group.

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: February 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)