Artificial Abortion, PONV(Post Operative Nausea and Vomiting)NCT05834361
The Time Point of Carboprost Methylate Administration and Perioperative Complications
A study testing early vaginal administration of carboprost methylate and delayed vaginal administration of carboprost methylate in people with Artificial Abortion, PONV(Post Operative Nausea and Vomiting), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Artificial Abortion, PONV(Post Operative Nausea and Vomiting)
- What is being tested?
- early vaginal administration of carboprost methylate and delayed vaginal administration of carboprost methylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion
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.
- Being tested
- early vaginal administration of carboprost methylate, delayed vaginal administration of carboprost methylate
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early vaginal administration of carboprost methylateDrug
In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.
delayed vaginal administration of carboprost methylateDrug
In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: early vaginal administration of carboprost methylate |
| 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. Receives: Drug: delayed vaginal administration of carboprost methylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total adverse events
total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.
Measured: Baseline (Before surgery)
Secondary outcomes (2)
Numerical rating scale (NRS) before surgery
NRS score before surgery (score from 0-10)(0 = no pain; 10 = worst pain imaginable)
Measured: Baseline (Before surgery)
Postoperative nausea and vomiting (PONV)
The pond percentage
Measured: 4 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Artificial Abortion, PONV(Post Operative Nausea and Vomiting)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834361
- Sponsor's protocol ID
- K23C0074
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26683499Pierce 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.
PubMed 30377555Hwang 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.
PubMed 29409965Zhao Y, Xue W, Chen W, Zhang D. Delayed Administration of Carboprost Methylate Reduces Perioperative Complications Without Affecting Cervical Ripening Effect in Surgical Abortion: A Randomized Controlled Trial. J Obstet Gynaecol Res. 2025 Oct;51(10):e70107. doi: 10.1111/jog.70107.
PubMed 41088336
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion
- ClinicalTrials.gov ID
- NCT05834361
- Acronym / sponsor ID
- K23C0074
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early administration of carboprost methylate | Experimental | Drug: early vaginal administration of carboprost methylateShortening the vaginal administration time of carboprost methylate, approximately 20 minutes before the surgery. Carboprost methylate was given when patients enter the operation room area. |
| delayed administration of carboprost methylate | Active comparator | Drug: delayed vaginal administration of carboprost methylateDelay the vaginal administration time of carboprost methylate, approximately 2 hours before the surgery. Carboprost methylate was given when patients were in the ward. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early vaginal administration of carboprost methylateIn this group, the administration time point of carboprost methylate is 20 minutes before the surgery. | Drug | early administration of carboprost methylate |
| delayed vaginal administration of carboprost methylateIn this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery. | Drug | delayed administration of carboprost methylate |
Primary outcome
Total adverse events
Time frame: Baseline (Before surgery)
total adverse events before anesthesia, including abdominal pain, nausea, vomiting, defecate desire and diarrhea.
2 secondary outcomes
Numerical rating scale (NRS) before surgery
Time frame: Baseline (Before surgery)
Postoperative nausea and vomiting (PONV)
Time frame: 4 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 26683499Allen 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.
- Background: PubMed 30377555Pierce 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.
- Background: PubMed 29409965Hwang 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.
- Derived from this study: PubMed 41088336Zhao Y, Xue W, Chen W, Zhang D. Delayed Administration of Carboprost Methylate Reduces Perioperative Complications Without Affecting Cervical Ripening Effect in Surgical Abortion: A Randomized Controlled Trial. J Obstet Gynaecol Res. 2025 Oct;51(10):e70107. doi: 10.1111/jog.70107.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early vaginal administration of carboprost methylate and delayed vaginal administration of carboprost methylate in people with Artificial Abortion, PONV(Post Operative Nausea and Vomiting), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total adverse events (time frame: Baseline (Before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834361, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.