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The Time Point of Carboprost Methylate Administration and Perioperative Complications

NCT ID: NCT05834361

Last Updated: 2023-04-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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Artificial Abortion, PONV(Post Operative Nausea and Vomiting)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

early vaginal administration of carboprost methylate

Intervention Type DRUG

In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.

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.

Group Type ACTIVE_COMPARATOR

delayed vaginal administration of carboprost methylate

Intervention Type DRUG

In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.

Interventions

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early vaginal administration of carboprost methylate

In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Allen RH, Goldberg AB. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). Contraception. 2016 Apr;93(4):277-291. doi: 10.1016/j.contraception.2015.12.001. Epub 2015 Dec 9.

Reference Type BACKGROUND
PMID: 26683499 (View on PubMed)

Pierce S, Bakker R, Myers DA, Edwards RK. Clinical Insights for Cervical Ripening and Labor Induction Using Prostaglandins. AJP Rep. 2018 Oct;8(4):e307-e314. doi: 10.1055/s-0038-1675351. Epub 2018 Oct 29.

Reference Type BACKGROUND
PMID: 30377555 (View on PubMed)

Hwang JY, Song SH. Optimal Dose of Vaginal Misoprostol for Cervical Ripening before Hysteroscopy: A Randomized Double-Blind Study. J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1031-1034. doi: 10.1016/j.jmig.2018.01.022. Epub 2018 Jan 31.

Reference Type BACKGROUND
PMID: 29409965 (View on PubMed)

Zhao Y, Xue W, Chen W, Zhang D. Delayed Administration of Carboprost Methylate Reduces Perioperative Complications Without Affecting Cervical Ripening Effect in Surgical Abortion: A Randomized Controlled Trial. J Obstet Gynaecol Res. 2025 Oct;51(10):e70107. doi: 10.1111/jog.70107.

Reference Type DERIVED
PMID: 41088336 (View on PubMed)

Other Identifiers

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K23C0074

Identifier Type: -

Identifier Source: org_study_id