The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study

The mode of placental delivery may contribute to an increase or decrease in the morbidity associated with CS, and many studies have shown it to be a key role in determining the blood loss during CS. Manual removal of the placenta has been implicated in increased blood loss during CS. However, other researchers concluded that it had no detrimental effect on blood loss

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: Manual placental separation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo/القاهرة
    • Cairo, Cairo/القاهرة, Egypt, 71350
      • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age (18 - 35) years.
• Primigravida.
• Unscarred uterus.
• Singleton pregnancy.
• Living baby.
• Body mass index (18 - 30) 37-40 weeks

Exclusion Criteria:

• Emergency cesarean section due to possibility of maternal distress and blood loss.
• Cesarean hysterectomy as the placenta will be removed with the uterus.
• Abnormally adherent placenta: Placenta accrete, percreta or placenta previa due to failure of placental separation.
• Previous cesarean section as the previous scar may affect placental separation.
• Body mass index less than 18 and more than 30 as extremes of body weight may be associated with increased risks of anemia, bleeding and/or infection.
• Suspected chorioamnionitis to decrease the risk of disseminated infection.
• Bleeding disorders to decrease blood loss.
• Multiple pregnancy due to larger placental volume and blood loss compared with singleton.
• Any pelvic surgery (Appendix - Ovarian cyst. - Ectopic Pregnancy - pelvic abscess)
• Women with medical illness e.g. pre-eclampsia, anemia (Hb less than 11 gm/dl), DM, Cardiac, Renal …etc. to decrease the risk of maternal morbidity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Spontaneous separation
Experimental: Manual separation	Procedure: Manual placental separation; Manual separation of the placenta from uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	The blood loss during cesarean section and in the first 24 hours postoperatively will be assessed in a standard manner. Blood will be measured after suction of the mount of amniotic fluid in a separate suction bottle. Amount of blood which collected from towels will be measured according to gravimetric method which reported by Liu et al. (2020). - EBV x (Hi-Hf)/Hi: Where the Hi is the preoperative blood hematocrit, Hf is the postoperative one and EBV is the estimated blood volume. The estimated blood volume could be calculated by multiplying weight times average blood volume which is around 65 ml/kg in females (Miller et al., 2000).	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Maii Nawara, Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 8, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: MS 290/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No