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

NCT05395585 | Completed DMC

• 1 other identifier: MS 290/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Spontaneous separation

NO INTERVENTION

Manual separation

EXPERIMENTAL

Procedure: Manual placental separation

Interventions

Manual placental separation PROCEDURE

Manual separation of the placenta from uterus

Manual separation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Cairo/القاهرة, 71350, Egypt

Location

Study Officials

• Maii Nawara

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 8, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)