The Time Point of Carboprost Methylate Administration and Perioperative Complications

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Artificial Abortion, PONV(Post Operative Nausea and Vomiting)

Treatments: Drug: early vaginal administration of carboprost methylate; Drug: delayed vaginal administration of carboprost methylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05834361

K23C0074

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

early administration of carboprost methylate

Experimental group

Description:

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.

Treatment:

Drug: early vaginal administration of carboprost methylate

delayed administration of carboprost methylate

Active Comparator group

Description:

Delay the vaginal administration time of carboprost methylate, approximately 2 hours before the surgery. Carboprost methylate was given when patients were in the ward.

Treatment:

Drug: delayed vaginal administration of carboprost methylate