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

A

Ain Shams University

Status

Completed

Conditions

Cesarean Section Complications

Treatments

Procedure: Manual placental separation

Study type

Interventional

Funder types

Other

Identifiers

NCT05395585
MS 290/2022

Details and patient eligibility

About

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

Enrollment

200 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Spontaneous separation
No Intervention group
Manual separation
Experimental group
Treatment:
Procedure: Manual placental separation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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