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

NCT ID: NCT05395585

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Spontaneous separation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Manual separation

Group Type: EXPERIMENTAL

Manual placental separation

Intervention Type: PROCEDURE

Manual separation of the placenta from uterus

Interventions

Manual placental separation

Manual separation of the placenta from uterus

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maii Nawara

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University Maternity Hospital

Cairo, Cairo/القاهرة, Egypt

Countries

Egypt

Other Identifiers

MS 290/2022

Identifier Type: -

Identifier Source: org_study_id