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临床试验/NCT05834361
NCT05834361已完成不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Total adverse events

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

early administration of carboprost methylate

Experimental

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.

干预措施: early vaginal administration of carboprost methylate (Drug)

delayed administration of carboprost methylate

Active Comparator

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

干预措施: delayed vaginal administration of carboprost methylate (Drug)

结局指标

主要结局

Total adverse events

时间窗: Baseline (Before surgery)

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

次要结局

  • Numerical rating scale (NRS) before surgery(Baseline (Before surgery))
  • Postoperative nausea and vomiting (PONV)(4 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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