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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395585
• Other study ID #: MS 290/2022
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 8, 2023

Study information

• Verified date: January 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 8, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage

Intervention

Procedure:
• Manual placental separation
Manual separation of the placenta from uterus

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo	Cairo/???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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