The Time Point of Carboprost Methylate Administration and Perioperative Complications

Not Applicable

Completed

• Conditions: Artificial Abortion, PONV(Post Operative Nausea and Vomiting)
• Interventions: Drug: early vaginal administration of carboprost methylate; Drug: delayed vaginal administration of carboprost methylate

• Registration Number: NCT05834361
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-03-31
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-04-28
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early administration of carboprost methylate	early vaginal 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.
delayed administration of carboprost methylate	delayed vaginal 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.

Primary Outcome Measures

Name	Time	Method
Total adverse events	Baseline (Before surgery)	total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China