Cesarean Section ComplicationsNCT05395585
The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
A study testing Manual placental separation in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Manual placental separation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 8 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (18 - 35) years.
- Primigravida.
- Unscarred uterus.
- Singleton pregnancy.
- Living baby.
- Body mass index (18 - 30) 37-40 weeks
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Manual placental separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual placental separationProcedure or surgery
Manual separation of the placenta from uterus
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous separation | No intervention | Not described |
| Manual separation | Experimental | Not described Receives: Procedure: Manual placental separation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022
- Primary completion1 Jan 2023
- Study completion8 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maii Nawara, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395585
- Sponsor's protocol ID
- MS 290/2022
- Status last verified
- Jan 2023
- First submitted
- 25 May 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
- ClinicalTrials.gov ID
- NCT05395585
- Acronym / sponsor ID
- MS 290/2022
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 8 Jan 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous separation | No intervention | – |
| Manual separation | Experimental | Procedure: Manual placental separation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age (18 - 35) years.
- Primigravida.
- Unscarred uterus.
- Singleton pregnancy.
- Living baby.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual placental separationManual separation of the placenta from uterus | Procedure or surgery | Manual separation |
Primary outcome
Blood loss
Time frame: 24 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Section Complications
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
Severe Pain, Cesarean Section Complications
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Enrolling by invitation
Using Empowered Relief and Education To Help Postpartum Women Recover After Cesarean Delivery
Cesarean Section Complications, Postpartum Care
Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Cesarean Section Complications, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maii Nawara study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual placental separation in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.