ClinicalTrials.gg
CompletedNCT05395585Updated Jan 20, 2023

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

An interventional study of Manual placental separation in Cesarean Section Complications, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Ain Shams University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Cesarean Section Complications
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • No intervention
    Spontaneous separation
  • Experimental
    Manual separation

    Procedure: Manual placental separation

Interventions

  • ProcedureManual placental separation

    Manual separation of the placenta from uterus

06

What researchers measure

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).

    Time frame: 24 hours

07

Study locations

1 site
  • Ain Shams University Maternity Hospital
    Cairo, Cairo/القاهرة 71350, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Jan 2023, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2022
First posted
May 27, 2022
StartActual
Jun 1, 2022
Primary completionActual
Jan 1, 2023
CompletionActual
Jan 8, 2023
Last update
Jan 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05395585
Responsible party
Sponsor
First posted
May 27, 2022
Start date
Jun 1, 2022
Primary completion
Jan 1, 2023
Completion
Jan 8, 2023
Last update
Jan 20, 2023

Study contacts

Maii Nawara
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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