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Umbilical Cord ClampingNCT04193345

The Impact of Early Versus Delayed Umbilical Cord Clamping in Preeclamptic Pregnant Patients During Cesarean Section

A study testing Documentation of Maternal blood loss and neonatal outcome in people with Umbilical Cord Clamping, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the different maternal and neonatal impacts of early versus delayed umbilical cord clamping among pregnant preeclamptic patients delivered by cesarean section Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Umbilical Cord Clamping
What is being tested?
Documentation of Maternal blood loss and neonatal outcome
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteEgypt
Study dates
1 Jan 2020to 31 May 2021
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women candidate for LSCS.
  • Age: 20-40 years old.
  • Maternal severe preeclampsia
  • CS under spinal anesthesia.
  • Singleton pregnancy

Who cannot join

  • Fetal death (IUFD).
  • Intrapartum surgical complications ( uterine artery injury or lower segment extension)
  • Medical disorders such as Diabetes mellitus or severe anemia
  • The need for immediate resuscitation like meconium aspiration .
  • Abnormal placentation or placental abruption
  • Liquor abnormalities ; oligo hydramnios
  • Anomalous fetus

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine - Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: The Maternal and Neonatal Impact of Early Versus Delayed Umbilical Cord Clamping Among Pregnant Severe Preeclampsia Patients Delivered by Cesarean Section

To compare the different maternal and neonatal impacts of early versus delayed umbilical cord clamping among pregnant preeclamptic patients delivered by cesarean section

Read the detailed description

The study will include 62 pregnant women attending for severe preeclampsia and cesarean delivery will be done at the Kasr Elaini hospital (faculty of medicine - Cairo university).

Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.

Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).

Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination.

Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.

Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests.

Group allocation: On the day of the scheduled surgery, participants will be randomly and equally assigned into two groups; early clamping group n= 31 ( umbilical cord to be clamped within 15 s ) and delayed clamping group , n= 31 ( umbilical cord to be clamped at 60 sec ) , In all groups , Neonates will be held in a sterile towel or blanket below the level of the incision on maternal abdomen or between her legs at cesarean section. Care was taken that no tension or traction was placed on the cord. A stopwatch was used to mark the time , patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby All cesarean sections will be done under spinal anesthesia by an assistant lecturer and the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, early cord clamping (< 15 seconds) or delayed cord clamping (after 60 sec) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps).

The number and the difference of weight of operative towels (before and after LSCS) and amount of blood in suction unit will be recorded.

A complete blood count test will be performed 12 hours after delivery. neonatal laboratory results (hemoglobin and hematocrit, )will be collected within 4 hours of age, initial serum bilirubin was collected at 12 hours of age then to be repeated at day 3 for follow up.

Estimated Blood Loss (EBL) will be evaluated as follows:

  1. The number of operative towels used. B. The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
  2. EBL calculation according to the following formula:

EBL= EBV x Preoperative hematocrit- Postoperative hematocrit Postoperative hematocrit Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).

The neonates clinical data, as APGAR Score, blood pressure, temperature, jaundice, pallor and cyanosis and respiratory distress syndrome will be collected by the attending neonatologist .All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the first 24 hours).

Being tested
Documentation of Maternal blood loss and neonatal outcome
Keywords
Delayed Umbilical Cord Clamping, Preeclamptic Patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Documentation of Maternal blood loss and neonatal outcomeOther

    Comparing and monitoring the maternal blood loss and neonatal effect of delayed umbilical cord clamping and early umbilical cord clamping after delivery of the baby durin cesarean delivery in severe preeclampsia

Study groups in NCT04193345
Study groupRoleWhat they receive
Early cord clampingActive comparatorThe umbilical cord will be clamped within 15 seconds from delivery of the baby
Receives: Other: Documentation of Maternal blood loss and neonatal outcome
Delayed cord clampingActive comparatorThe umbilical cord will be clamped after 60 seconds from delivery of the baby
Receives: Other: Documentation of Maternal blood loss and neonatal outcome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the intra operative maternal blood loss

    To compare the early versus of delayed cord clamping on intra operative blood loss in pregnant patients diagnosed with severe preeclampsia

    Measured: 24 hours

Secondary outcomes (2)
  1. the neonatal outcome

    To compare the neonatal benefit from delayed cord clamping group versus early clamping in patients with severe preeclampsia during cesarean delivery

    Measured: 4 days

  2. The incidence of post partum hemorrhage

    To assess the extra need for ecbolics and the actual incidence of post partum hge with both methods

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Jan 2020
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193345
Sponsor's protocol ID
MD-74-2019
Status last verified
Feb 2022
First submitted
8 Dec 2019
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rashwan A, Eldaly A, El-Harty A, Elsherbini M, Abdel-Rasheed M, Eid MM. Delayed versus early umbilical cord clamping for near-term infants born to preeclamptic mothers; a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Jun 25;22(1):515. doi: 10.1186/s12884-022-04831-8.

    PubMed 35752762

Questions about this trial

What is this clinical trial studying?

A study testing Documentation of Maternal blood loss and neonatal outcome in people with Umbilical Cord Clamping, run by Cairo 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 5 inclusion and 7 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 23 Feb 2022. 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?

the intra operative maternal 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?

On the ClinicalTrials.gov record for NCT04193345, which also lists 1 linked publication.

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 23 Feb 2022.

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