Trial intelligence / Profile preview

Melatonin for Pain and Blood Loss in Cesarean Section

NCT01572805Phase 2

Key facts

Status
Completed
Start
Feb 2012
Primary completion
Sep 2012
Countries
1
Sponsor
Qazvin University of Medical Sciences
Modality
Small Molecules
Conditions
postoperative painpostpartum hemorrhage (PPH)
01

Overview

Phase 2, randomised, double-blind trial of melatonin in postoperative pain and postpartum hemorrhage (PPH) (3 arms), sponsored by Qazvin University of Medical Sciences. Primary endpoints: Time to first requirement of analgesic supplement at 24 hours and Amount of blood loss after cesarean delivery. Started Feb 2012; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Melatonin 3mg

    Melatonin 3mg sublingual

  • Melatonin 6mg

    Melatonin 6mg sublingual

  • Placebo

    Placebo sublingual

03

Who it enrols

Pregnant women at term (37-40 weeks) scheduled for elective or emergency lower segment cesarean section. Excludes women with risk factors for postpartum hemorrhage (multiple gestation, antepartum hemorrhage, polyhydramnios, >=2 previous C-sections, uterine rupture history), significant heart/liver/renal disease, anemia (Hb < 8 g%), or coagulopathy.

04

Endpoints

Primary

  • Time to first requirement of analgesic supplement

  • Amount of blood loss after cesarean delivery

Secondary

  • Hemodynamic variables

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