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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05395585
Enrollment
200
Registered
2022-05-27
Start date
2022-06-01
Completion date
2023-01-08
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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

Interventions

PROCEDUREManual placental separation

Manual separation of the placenta from uterus

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood loss24 hoursThe 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026