Clinical trial NCT05834361: 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
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Abortion, PONV(Post Operative Nausea and Vomiting)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total adverse events
timeFrame: Baseline (Before surgery)
Secondary outcomes:
measure: Numerical rating scale (NRS) before surgery
timeFrame: Baseline (Before surgery)
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 4 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
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.
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.
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.