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

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Manual placental separation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cesarean Section Complications

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Spontaneous separation

Manual separation

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
January 19, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05395585
Brief Title
The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
Official Title
The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spontaneous separation
Arm Type
No Intervention
Arm Title
Manual separation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Manual placental separation
Intervention Description
Manual separation of the placenta from uterus
Primary Outcome Measure Information:
Title
Blood loss
Description
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).
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maii Nawara
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
State/Province
Cairo/القاهرة
ZIP/Postal Code
71350
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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