MedDataX Logo

Different Routes of Misoprostol Prior to First Trimester Surgical Abortion

NCT ID: NCT02480543

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abortion, Induced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PO Misoprostol

Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage

Group Type ACTIVE_COMPARATOR

Misoprostol (cytotec)

Intervention Type DRUG

PV Misoprostol

Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage

Group Type ACTIVE_COMPARATOR

Misoprostol (cytotec)

Intervention Type DRUG

Buccal Misoprostol

Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage

Group Type ACTIVE_COMPARATOR

Misoprostol (cytotec)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol (cytotec)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age \<13+0 weeks
* Written consent supplied

Exclusion Criteria

* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
* Prostaglandin allergy
* Genital infection
* Space-occupying lesion in the endocervical canal
* Prior cervical surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadas Ganer Herman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hadas Ganer Herman, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edith Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hadas Ganer Herman, MD

Role: CONTACT

Phone: 972-077-2066960

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hadas Ganer Herman, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0085-15-WOMC

Identifier Type: -

Identifier Source: org_study_id