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NCT Number: NCT02083107

Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients booked for elective cesarean section.
  • Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section

Exclusion criteria

  • Primigravida.
  • Blood dyscrasias.
  • Large fibroids.
  • Multiple pregnancies.
  • Overdistended uterus eg. Hydramnios.
  • Pre-eclampsia.
  • Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
  • Previous history of PPH.
  • Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
  • Placenta previa.
  • Contraindication to spinal anesthesia.
  • Previous myomectomy.
  • Previous two or more C.S.

Treatment and study plan

Misoprostol

Drug

Comparison of different routes of administration of 400 micro gram misoprostol

Other names: Misotac, Cytotec

Placebo

Other

Primary outcomes

  1. Intraoperative Blood Loss

    Time frame: from start of cesarean section till the end of operation (average one hour)

Secondary outcomes

  1. Need for Extra Ecbolics (Oxytocin).

    Time frame: from start of cesarean section till the end of operation (average one hour)

  2. APGAR Score

    Time frame: 1minute and 5 minutes from delivery of the fetus

    The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).

  3. Time to Resume Bowel Habits

    Time frame: average 24 hours

  4. Need for Extra Analgesics

    Time frame: average 24 hours

  5. Need for Postoperative Blood Transfusion

    Time frame: average 24 hours

  6. Incidence of Wound Sepsis

    Time frame: upto one week

  7. Incidence of Adverse Effects

    Time frame: 24 hours

Other outcomes

  1. Change in Hemoglobin Concentration

    Time frame: 24 hours postoperative from baseline hemoglobin

  2. Change in Hematocrite Value

    Time frame: 24 hours postoperative from baseline hematocrite value

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2014
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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