Current partner codePEPTIDESDE
NCT05670886·Not applicable·INTERVENTIONAL

Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation

Status

Unknown

Phase

Not applicable

Enrollment

110

Locations

1

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions. PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3). PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5) Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%. Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions . One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.

Full detailed description

This study is a randomized controlled study including a total number of 110 patients presenting to Kasr Al-ainy obstetrics and gynecology hospital for CS delivery. Ethical committee approved this study. Patients are equally \& randomly divided into two equal groups . Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section undergoing bilateral uterine artery ligation and received carbetocin. Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only. Pregnant patients aging between 18 to 42 undergoing cesarean section for multiple pregnancy are included in this study , while Patients with Placenta previa or accrete , Ante-partum hemorrhage , patient refusing to participate , patients with medical disorders and patients with pre-operative HB less than 9 gm/dl were excluded from the study. Informed consent was taken from involved patients after explanation of the procedures and their complications , and allocated patients were subjected to : (1) History taking regarding age , parity , previous CS , previous PPH , menstrual , medical and surgical history . (2) Examination : including general exam.(BMI , Blood Pressure ) , Abdominal examination ( Leopold's maneuvers , CS scars , fetal heart sounds , fundal level ) \& local vaginal examination . (3)Ultrasound was done to detect number of fetuses , gestational age , presentations , placental sites , amount of liquor \& fetal weight. Patients were prepared for CS delivery after requesting pre-operative labs. Anesthesia: spinal is mainly used except in cases were general anesthesia is indicated as fetal distress. Urinary catheterization and skin preparation was done. Skin incision using Pfannenstiel incision , opening abdomen in layers . The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . Group (A): a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection \& bilateral uterine artery ligation were done 2cm below the uterine incision. Group (B): only a single dose of 100 microgram carbetocin (Pabal® , ferring ) IV injection administered after the delivery of the infant . Closure of uterine incision \& proper hemostasis were done . The abdomen was closed in layers . Patients were observed postpartum for vaginal bleeding , vitals , uterine tone , urine output \& postoperative hemoglobin. Operative time was calculated from the time of skin incision to tome of skin closure. Blood loss was calculated by Visual estimation by different operating room staff: the anesthetist, the obstetrician as well as the scrub nurse ( estimate the loss by careful observation of the operative field during surgery and report it at the end.) \& by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set. PPH was defined as blood loss of ≥1,000 ml following delivery (11). Statistical Analyses were done using the Statistical Package for the Social Sciences (SPSS) , version 23. Quantitative Data were reported as mean± SD, while qualitative data were reported as number and percentage. The chi square test was used to compare categorical variables; P value \<0.05 was considered significant.

Interventions

Treatment arms and agents.

PROCEDURE

uterine artery ligation

The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally Lower uterine incision was done followed by fetal extraction and placental delivery . bilateral uterine artery ligation were done 2cm below the uterine incision.

Timeline

From registration to results.

  1. First posted

    Jan 4, 2023

  2. Study start

    Jun 1, 2022

  3. Primary completion

    Jan 5, 2023

  4. Study completion

    Jan 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Jan 4, 2023

Outcomes

What the study measures.

Primary outcomes

mean Blood loss after placental separation

Time frame · 30 minutes

by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

Secondary outcomes

Number of Participants with postpartum hemorrhage

Time frame · 12 hours

number pf participants with blood loss \> 1000ml

The number of participant needed for blood transfusion

Time frame · 24 hours

Calculation of the number of participant needed for blood transfusion

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
42 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * women undergoing cesarean section * multiple pregnancy Exclusion Criteria: * Placenta previa. * Ante-partum hemorrhage. * patient refuse to participate

Study locations

1 registered sites.

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

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

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