Comparing Blood Loss During Caesarean Section Between Manual Separation of Placenta & Conservative Management
Condition: Haemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      to compare the blood loss during caesarean section between two different methods of
      separating the placenta after fetal extraction, keeping in mind that most blood loss occurs
      after placental separation.
    

Detailed description: 
      We are planning a study of a continuous response variable from independent control and
      experimental subjects with 1 control(s) per experimental subject. In a previous study1 the
      response within each subject group was normally distributed with standard deviation up to
      272. If the true difference in the experimental and control means is 37, we will need to
      study 249 experimental subjects and 249 control subjects to be able to reject the null
      hypothesis that the population means of the experimental and control groups are equal with
      probability (power) 0.8. The Type I error probability associated with this test of this null
      hypothesis is 0.5. To allow for 15% drop, the sample on each arm will be increased to 287.

      After approval of the ethical & scientific committee of the obstetrics & gynecology
      department, Kasr Alainy Hospital, Cairo University. A randomized controlled trial involving
      at least 574 patients will be undertaken in which, all patients will be randomized in to two
      groups, with a closed envelope system containing equal number allocations for both groups
      (1:1 bias) by the operating room nurse. Informed consent will be taken from all patients
      before caesarean section.

      Group A will contain 287 patients in which manual separation of the placenta will be done
      immediately after fetal extraction & cord clamping, where the fingers of the surgeon will be
      insinuated between the margin of the placenta and the uterine cavity, then by sawing movement
      and controlled traction by the other hand till placenta is separated from the uterine cavity.
      Group B will also contain 287 patients but following fetal extraction and cord clamping, the
      placenta will be left insitu & uterus is massaged awaiting spontaneous placental separation.

      In both groups a uterotonic agent Oxytocin 5IU( syntocinon® Sandoz Pharmaceuticals
      Corporation East Hanover, New Jersey) will be given I.V in 250 ml ringer solution immediately
      after cord clamping, and the uterus is exteriorized,& the caesarean is performed by surgeons
      of equal training level (Senior residants). Any serious tears or extensions into the lower
      uterine segment, along with any major bleeding points on the suture line will be repaired
      before attending to the placenta in both groups to prevent any serious blood loss before
      placental separation, which will cause the results to be biased & increase the risk of major
      hemorrhage for the patient. The blood lost will be measured by recording the fluid in the
      suction apparatus before and after placental separation, keeping in mind that most fluid in
      the apparatus before fetal extraction was amniotic fluid and therefore will be deducted from
      the total. The net amount of fluid in the suction apparatus will be added the volume of fluid
      collected from blood soaked sterilized towels used after fetal extraction and the under
      buttocks drapes placed under the patient.

      The volume of fluid collected in soaked materials will be calculated according to (2) AWHONN
      Practice Brief Number 1, where the dry weight of these materials in grams before the
      operation is recorded and subtracted from the soaked weight & converted to milliliters. The
      net weight will be calculated through the following equation WET Item Gram Weight - DRY Item
      Gram Weight = Milliliters of Blood within the item. (2) Descriptive data was recorded along
      with blood loss after placental separation, and the time taken for placenta to spontaneously
      separate in group B. Preoperative & 6 hour postoperative hemoglobin will be recorded in both
      groups. All statistical calculations were done using computer program SPSS (Statistical
      Package for the Social Science; SPSS Inc., Chicago, IL, USA) release 15 for Microsoft Windows
      (2006). PS Power and Sample size calculations software, version 2.1.30 for MS windows, was
      used to calculate sample size (Dupont & Vanderbilt, USA)

      References:

        1. Gol M, Baloglu A, Aydin C, Ova L, Yensel U, Karci L.(2004): Does manual removal of the
           placenta affect operative blood loss during cesarean section? Eur J Obstet Gynecol
           Reprod Biol. 2004 Jan 15;112(1):57-60.

        2. AWHONN Practice Brief (2014): Quantification of Blood Loss: AWHONN Practice Brief Number
           1. JOGNN, 00, 1-3; 2014. DOI: 10.1111/1552-6909.12519.
    

Intervention name(s): manual seperation of the placenta; Conservative separation of placenta
Intervention type(s): Procedure; Procedure
Intervention description(s): manual separation of the placenta will be done immediately after fetal extraction & cord clamping, where the fingers of the surgeon will be insinuated between the margin of the placenta and the uterine cavity, then by sawing movement and controlled traction by the other hand till placenta is separated from the uterine cavity; Conservative separation of placenta:
in group B but following fetal extraction and cord clamping, the placenta will be left insitu & uterus is massaged awaiting spontaneous placental separation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: blood loss; caesarean section ; manual placental separation