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NCT05170230·Not applicable·INTERVENTIONAL

The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

TerlipressinCarbetocinOtherUnknown

Status

Unknown

Phase

Not applicable

Enrollment

99

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

Full detailed description

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms: * Arm 1: intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure * Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure * Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

Interventions

Treatment arms and agents.

DRUG

Terlipressin

intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

Timeline

From registration to results.

  1. First posted

    Dec 27, 2021

  2. Study start

    Feb 27, 2022

  3. Primary completion

    Dec 30, 2024

  4. Study completion

    Jun 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2024

Outcomes

What the study measures.

Primary outcomes

intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy

Time frame · 12 hours

measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Secondary outcomes

1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin

Time frame · 24 hours

compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy

2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time

Time frame · 12 hours

2\. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Eligibility

Who can take part.

Minimum age
16 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria 1. Women aged 16-45 years 2. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm) 3. Baseline hemoglobin ≥9 g/dl 4. No contra-indications to the use of glyopressin or carbitocin 5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility 6. Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) Exclusion Criteria: 1. Previous myomectomy 2. History of bleeding disorders 3. Concurrent anticoagulation therapy 4. History of Uncontrolled ischaemic heart disease 5. Any pelvic abnormalities requiring concomitant surgery 6. Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery 7. Inability to understand and provide written informed consent

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Wael El Banna Clinic

Maadi, Egypt

Publications

Results and literature.

PMID 23498888 ↗Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15.PMID 30056355 ↗Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTerlipressin trial dashboard →DatabaseTerlipressin database entry →ResearchTerlipressin research guide →TrialsCarbetocin trial dashboard →DatabaseCarbetocin database entry →ResearchCarbetocin research guide →