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The Time Point of Carboprost Methylate Administration and Perioperative Complications

Primary Purpose

Artificial Abortion, PONV(Post Operative Nausea and Vomiting)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
early vaginal administration of carboprost methylate
delayed vaginal administration of carboprost methylate
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Artificial Abortion, PONV(Post Operative Nausea and Vomiting)

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early administration of carboprost methylate

delayed administration of carboprost methylate

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numerical rating scale (NRS) before surgery
NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)
Postoperative nausea and vomiting (PONV)
The pond percentage

Full Information

First Posted
April 5, 2023
Last Updated
April 26, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05834361
Brief Title
The Time Point of Carboprost Methylate Administration and Perioperative Complications
Official Title
The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Abortion, PONV(Post Operative Nausea and Vomiting)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early administration of carboprost methylate
Arm Type
Experimental
Arm Description
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.
Arm Title
delayed administration of carboprost methylate
Arm Type
Active Comparator
Arm Description
Delay the vaginal administration time of carboprost methylate, approximately 2 hours before the surgery. Carboprost methylate was given when patients were in the ward.
Intervention Type
Drug
Intervention Name(s)
early vaginal administration of carboprost methylate
Intervention Description
In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.
Intervention Type
Drug
Intervention Name(s)
delayed vaginal administration of carboprost methylate
Intervention Description
In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.
Primary Outcome Measure Information:
Title
Total adverse events
Description
total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.
Time Frame
Baseline (Before surgery)
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS) before surgery
Description
NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)
Time Frame
Baseline (Before surgery)
Title
Postoperative nausea and vomiting (PONV)
Description
The pond percentage
Time Frame
4 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26683499
Citation
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.
Results Reference
background
PubMed Identifier
30377555
Citation
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.
Results Reference
background
PubMed Identifier
29409965
Citation
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.
Results Reference
background

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The Time Point of Carboprost Methylate Administration and Perioperative Complications

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