The Time Point of Carboprost Methylate Administration and Perioperative Complications

April 26, 2023 updated by: Peking Union Medical College Hospital

The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion

Artificial abortion is the most widely used procedure in termination of first-trimester pregnancy. Cervical ripening before the operation guarantees operative convenience and decreases complications. An overstrained cervical dilation associates with uterine perforation, cervical laceration and cervical incompetence. To address the issue, various mechanical and pharmaceutical methods have been applied to prepare the cervix before transvaginal procedures. Prostaglandin analogues (PGs) play an important role in ripening the cervix or promoting uterine contraction in gynecology and obstetrics. As most tissues express prostaglandin receptors, vomiting, nausea, fever, diarrhea and abdominal pain can hardly be avoided with PGs administration. Longer PGs action contributes to better cervical ripening, but more uncomfortableness at the same time. These annoying symptoms may affect the participants' satisfaction and increase perioperative risks. To balance the safety and effectiveness of the surgery as well as patients' feeling, a proper timing for cervical ripening should be investigated. However, the administration timing of PGs has not reached a broad consensus, ranging from 16 hours to 2 hours before surgery. Carboprost methylate (CM), a PG-F2α analogue, has been used nationwide for cervical ripening in China. To minimize the side effects of PGs without affecting cervical ripening, the investigators intended to explore shortening the action time of CM in cervical preparation before artificial abortion. Thus, the investigators conducted this prospective cohort study and aimed to examine the efficacy of early and delayed vaginal administration of CM before surgery, and optimized both the perioperative safety and participants' convenience. The investigators hypothesize that early vaginal administration of CM would not affect the cervical ripening status, but will greatly reduce the unpleasant complications among the participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-59
  • Signed informed consent.
  • Admitted to hospital for surgical termination of unplanned pregnancy
  • Gestational weeks range between 7 to 10
  • Average diameter of the gestational sac was no larger than 4cm

Exclusion Criteria:

  • Massive vaginal bleeding
  • Severe abdominal pain at admission (numerical rating scale, NRS>3)
  • Genital tract infection
  • Contraindication of PGs (including uncontrolled hypertension, asthma, glaucoma, severe heart disease or allergy to prostaglandins, etc.)
  • Prior history of vaginal delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early administration of carboprost methylate
Shortening the vaginal administration time of carboprost methylate, approximately 20 minutes before the surgery. Carboprost methylate was given when patients enter the operation room area.
Drug: early vaginal administration of carboprost methylate
In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.
Active Comparator: delayed administration of carboprost methylate
Delay the vaginal administration time of carboprost methylate, approximately 2 hours before the surgery. Carboprost methylate was given when patients were in the ward.
Drug: delayed vaginal administration of carboprost methylate
In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total adverse events
Time Frame: Baseline (Before surgery)
total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.
Baseline (Before surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS) before surgery
Time Frame: Baseline (Before surgery)
NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)
Baseline (Before surgery)
Postoperative nausea and vomiting (PONV)
Time Frame: 4 hours after surgery
The pond percentage
4 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23C0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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