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NCT Number: NCT05834361

The Time Point of Carboprost Methylate Administration and Perioperative Complications

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.

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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early vaginal administration of carboprost methylate

Drug

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

delayed vaginal administration of carboprost methylate

Drug

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

Primary outcomes

  1. Total adverse events

    Time frame: Baseline (Before surgery)

    total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.

Secondary outcomes

  1. 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)

  2. Postoperative nausea and vomiting (PONV)

    Time frame: 4 hours after surgery

    The pond percentage

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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