An interventional study of early vaginal administration of carboprost methylate and delayed vaginal administration of carboprost methylate in Artificial Abortion, PONV(Post Operative Nausea and Vomiting), sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 120 is above the median of 107 across 935 interventional studies indexed under Vomiting.
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Exclusion Criteria:
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.
Drug: early 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.
Drug: delayed vaginal administration of carboprost methylate
In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.
In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.
Total adverse events
total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.
Time frame: Baseline (Before surgery)
Numerical rating scale (NRS) before surgery
NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)
Time frame: Baseline (Before surgery)
Postoperative nausea and vomiting (PONV)
The pond percentage
Time frame: 4 hours after surgery
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital