The Time Point of Carboprost Methylate Administration and Perioperative Complications

Study Overview
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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.

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

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

Intervention / Treatment
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* Drug: early vaginal administration of carboprost methylate
* Drug: delayed vaginal administration of carboprost methylate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early administration of carboprost methylate<br>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<br>* In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.<br>|
| Active Comparator: delayed administration of carboprost methylate<br>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<br>* In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total adverse events | total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea. | Baseline (Before surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) before surgery | NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable) | Baseline (Before surgery) | 
| Postoperative nausea and vomiting (PONV) | The pond percentage | 4 hours after surgery |