CompletedNot Applicable

Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

Egypt128 participantsStarted 2023-08-31

Plain-language 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%

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Intraoperative blood loss (defined as blood loss ≥500 cc)

Timeframe: First 2 hours from the starting of the operation

Intraoperative blood loss (defined as blood loss ≥500 cc)

Timeframe: First 2 hours from the starting of the operation

Trial details

NCT IDNCT06049160

SponsorEgymedicalpedia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-20

View on ClinicalTrials.gov More Blood Loss, Surgical trials