Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

Sponsor

Egymedicalpedia (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06049160

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

42.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical Blood Loss, Postoperative	Drug: Misoprostol	N/A

Detailed Description

In resource-limited countries, postpartum hemorrhage (PPH) remains the leading cause of maternal mortality. The increased rates of caesarean delivery have been incriminated as the primary cause behind the rise in PPH. PPH after a caesarean delivery has been defined as blood loss over 1000 ml. The estimated prevalence rate of PPH is in the range of 0.6%-6.4%.

Increased blood loss after CD reflects several factors, including surgical incisions, lack of background uterine contraction, and manual removal of placenta rather than waiting for its spontaneous separation after placental bed retraction. Minimizing blood loss during delivery is an important preventive health objective aimed at reducing postpartum anemia and related morbidity .

It has been reported that the prevalence of postpartum anemia in low-income countries is approximately 50%-80%. The major cause of postpartum anemia is blood loss at delivery, especially in presence of prepartum anemia. Postpartum anemia constitutes an appreciable health problem among women of reproductive age and is associated with reduced quality of life, impaired cognition, emotional instability, and depression.

Oxytocin is routinely used by obstetricians to prevent excessive blood loss during CD. Oxytocin is the uterotonic of choice in obstetric medicine. Both the Royal College of Obstetricians and Gynecologists and the American College of Obstetricians and Gynecologists currently recommend the routine use of oxytocin (5 IU bolus dose or infusion, respectively) after the delivery of the infant as a prophylactic measure against PPH. However, oxytociin is a dangerous drug with serious adverse effects such as hypotension, tachyc ardiaand myocardial ischemia .

Misoprostol is a prostaglandin E1 analogue that effectively prevents and treats PPH owin g to its uterotonic properties. It can be used through different routes: oral; sublingual; bucc al; rectal; and intrauterine with similar efficacy to oxytocin in reducing blood loss. The benefits of misoprostol (cervical dilation and uterine contractions) and its adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose dependent .

Misoprostol is affordable and widely available, easily administered via multiple routes ( vaginal, rectal, sublingual, and oral), and has a good safety profile if properly administered and monitored, all of which make it the standard treatment option for PPH in low-resource settings.

Misoprostol administered vaginally is affected by vaginal acidity and the bacterial micro-environment. Sublingual route has the highest peak concentration; however, it is also associated with the highest incidence of adverse effects due to high peak concentrati on. Rectally administered misoprostol is associated with slower absorption, lower peak c oncentration levels, and reduced adverse effects compared with the oral and sublingua l routes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

A Comparative Study Between Preoperative and Postoperative Rectal Misoprostol in the Reduction of Blood Loss During and After Elective Cesarean Section : A Double Blinded Randomized Controlled Trial

Actual Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A: 64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure).	Drug: Misoprostol All participants will be assigned for giving misoprostol rectally either preoperative or postoperative Other Names: Syntocinon
Active Comparator: Group B 64 participants who will receive post-operative rectal misoprostol only (600μg of rectal misoprostol after closure of the abdomen).	Drug: Misoprostol All participants will be assigned for giving misoprostol rectally either preoperative or postoperative Other Names: Syntocinon

Arm

Intervention/Treatment

Active Comparator: Group A:

64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure).

Drug: Misoprostol

All participants will be assigned for giving misoprostol rectally either preoperative or postoperative

Other Names:

Syntocinon

Active Comparator: Group B

64 participants who will receive post-operative rectal misoprostol only (600μg of rectal misoprostol after closure of the abdomen).

Drug: Misoprostol

All participants will be assigned for giving misoprostol rectally either preoperative or postoperative

Other Names:

Syntocinon

Outcome Measures

Primary Outcome Measures

Intraoperative blood loss (defined as blood loss ≥500 cc) [First 2 hours from the starting of the operation]
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level

Secondary Outcome Measures

Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss > 1000cc during first 24 hours) [first 24 hours after C-Section]]
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Gestational age ( 37 to 41 weeks).
Singleton healthy fetus.
Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
Body mass index of (25-30 Kg/m2).
Normal coagulation profile.
Normal amniotic fluid volume assessed by amniotic fluid index.

Exclusion Criteria:

Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium.
Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids.
Antepartum hemorrhage ( placenta previa and placental abruption).
Women who will undergo caesarean section because of failure of induction of labor.