A randomized controlled trial to compare the effectiveness of
trans-abdominal uterine massage versus sustained uterine compression, started
after delivery of the placenta, in reducing blood loss and on maternal pain
after a vaginal delivery.
This trial will be a prospective randomized,
trial that will be conducted at the American University of Beirut Medical
Center - Delivery Suite. Women who are expected to
deliver vaginally will be evaluated for potential participation during their
prenatal care during the last 2 months of pregnancy at the Women’s Health Center
(WHC) or Outpatient Department (OPD). They will be handled the IRB-approved
consent form and will be given enough time to read it and return signed in the
next antenatal visit. If they are not followed up at these facilities, they
will be approached upon presentation to the Delivery Suite.
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Study subjects will
be randomized using a computer-generated random number sequence to a 1:1 ratio.
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At delivery, a sealed
opaque envelope containing the randomization number and data sheet will be
opened by the PGYII immediately after delivery of the placenta, for each
consenting patient.
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As a
result of the nature of the intervention, neither participants nor research
staff will be blinded to group allocation.
Inclusion criteria include women giving birth vaginally, aged between 20 and 40 years, with a singleton pregnancy, gestational age of 36 or more weeks, and with fewer than three previous childbirths.
Exclusion criteria include multiple gestation, fetal malpresentation, the third stage of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis, three or more previous induced abortions, hypertensive disorders of pregnancy, fetal death, polyhydramnios, hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate infusion, abruptio placentae and having an abdominal wall too thick to palpate the fundus of the uterus or to perform uterine massage or compressions after delivery. Screening for eligibility will be accomplished by checking the medical record. Baseline information will collected from each participant.