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.
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.
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:
- 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).
- 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).
- Conditions
- Umbilical Cord Clamping
- 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 group | Role | What they receive |
|---|---|---|
| Early cord clamping | Active comparator | The 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 clamping | Active comparator | The 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.
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)
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
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.
- First posted10 Dec 2019
- Study start1 Jan 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord ClampingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moutaz Sherbini, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maternal and Neonatal Impact of Early Versus Delayed Umbilical Cord Clamping Among Pregnant Severe Preeclampsia Patients Delivered by Cesarean Section
- ClinicalTrials.gov ID
- NCT04193345
- Acronym / sponsor ID
- MD-74-2019
- Conditions
- Umbilical Cord Clamping
- Keywords
- Delayed Umbilical Cord Clamping, Preeclamptic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Dec 2019 (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.
To compare the different maternal and neonatal impacts of early versus delayed umbilical cord clamping among pregnant preeclamptic patients delivered by cesarean section
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:
- 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).
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping | Active comparator | Other: Documentation of Maternal blood loss and neonatal outcomeThe umbilical cord will be clamped within 15 seconds from delivery of the baby |
| Delayed cord clamping | Active comparator | Other: Documentation of Maternal blood loss and neonatal outcomeThe umbilical cord will be clamped after 60 seconds from delivery of the baby |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women candidate for LSCS.
- Age: 20-40 years old.
- Maternal severe preeclampsia
- CS under spinal anesthesia.
- Singleton pregnancy
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Documentation of Maternal blood loss and neonatal outcomeComparing 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 | Other | Delayed cord clamping, Early cord clamping |
Primary outcome
the intra operative maternal blood loss
Time frame: 24 hours
To compare the early versus of delayed cord clamping on intra operative blood loss in pregnant patients diagnosed with severe preeclampsia
2 secondary outcomes
the neonatal outcome
Time frame: 4 days
The incidence of post partum hemorrhage
Time frame: 24 hours
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 23 Feb 2022.
- Derived from this study: PubMed 35752762Rashwan 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Umbilical Cord Clamping
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Not yet recruiting
"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"
Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes
Recruiting
Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.