Gestational Diabetes MellitusNCT04369313
Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers
A study testing delayed cord clamping and early cord clamping in people with Gestational Diabetes Mellitus and Neonatal Hyperbilirubinemia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Neonatal Hyperbilirubinemia, Neonatal Asphyxia
- What is being tested?
- delayed cord clamping and early cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Apr 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- People in the study should meet the following inclusion criteria:
- Must be a singleton pregnancy
- Clinical diagnosis of gestational diabetes mellitus according to ACOG Practice Bulletin
Who cannot join
- Pregnant women and neonates were excluded if they met the exclusion criteria (not included in if meeting one of following items )
- Maternal clinical diseases (hypertension disorders, abnormal liver function, Rhesus negative blood group or other blood system disease)
- Maternal other pregnancy complications (polyhydramnios, oligohydramnios, placenta praevia, and abruptio placentae).
- Delivery before 37 weeks or after 42 weeks
- Neonatal weight was < 2.5 kg or>4.0 kg
- Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
- Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
ying hua, Doctor, 13676403165, wzfeyhy1015@126.com
About this study
Official title: Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers
Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour.
Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs.
Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.
- Being tested
- delayed cord clamping, early cord clamping
- Medical subject headings
- Diabetes, Gestational, Hyperbilirubinemia, Neonatal, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cord clampingProcedure or surgery
umbilical cord clamping more than 30 seconds after birth
early cord clampingProcedure or surgery
umbilical cord clamping within 15 seconds after birth
| Study group | Role | What they receive |
|---|---|---|
| delayed cord clamping | Experimental | clamping the cord at least 30s at birth Receives: Procedure: delayed cord clamping |
| early cord clamping | Other | umbilical cord clamping before 15 seconds Receives: Procedure: early cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal cord acid-base status
arterial cord samples were analyzed within 15 min by blood gas analyzer
Measured: within the 15 minutes after delivery
neonatal transcutaneous bilirubin level
The transcutaneous bilirubin was measured by the uniform TcB device three times a day
Measured: within the 1 to 3 days of age
Number of infants with neonatal jaundice requiring phototherapy
the infants need phototherapy because of high bilirubin level
Measured: within the 1 to 3 days of age
Number of infants with neonatal hyperbilirubinemia
the infants need phototherapy because of high bilirubin level
Measured: within the 1 to 3 days of age
Secondary outcomes (1)
neonatal initial blood glucose levels
The initial blood glucose levels were measured within 30 minutes after birth and before breastfeeding
Measured: within the 30 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Sep 2019
- Primary completion1 Jul 2020
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369313
- Sponsor's protocol ID
- SAHoWMU-CR2020-07-107
- Status last verified
- Mar 2021
- First submitted
- 27 Apr 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao X, Xu A, Lu X, Chen B, Hua Y, Ma Y. Association of phthalates exposure and sex steroid hormones with late-onset preeclampsia: a case-control study. BMC Pregnancy Childbirth. 2024 Sep 3;24(1):577. doi: 10.1186/s12884-024-06793-5.
PubMed 39227873Pan S, Lu Q, Lan Y, Peng L, Yu X, Hua Y. Differential effects of delayed cord clamping on bilirubin levels in normal and diabetic pregnancies. Eur J Pediatr. 2022 Aug;181(8):3111-3117. doi: 10.1007/s00431-022-04536-2. Epub 2022 Jun 25.
PubMed 35751710Shao H, Lan Y, Qian Y, Chen R, Peng L, Hua Y, Wang X. Effect of later cord clamping on umbilical cord blood gas in term neonates of diabetic mothers: a randomized clinical trial. BMC Pediatr. 2022 Mar 1;22(1):111. doi: 10.1186/s12887-022-03170-z.
PubMed 35232426
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers
- ClinicalTrials.gov ID
- NCT04369313
- Acronym / sponsor ID
- SAHoWMU-CR2020-07-107
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 30 Apr 2020 (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.
Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour.
Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs.
Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed cord clamping | Experimental | Procedure: delayed cord clampingclamping the cord at least 30s at birth |
| early cord clamping | Other | Procedure: early cord clampingumbilical cord clamping before 15 seconds |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a singleton pregnancy
- Clinical diagnosis of gestational diabetes mellitus according to ACOG Practice Bulletin
Key exclusion criteria (7 listed)
- Pregnant women and neonates were excluded if they met the exclusion criteria (not included in if meeting one of following items )
- Maternal clinical diseases (hypertension disorders, abnormal liver function, Rhesus negative blood group or other blood system disease)
- Maternal other pregnancy complications (polyhydramnios, oligohydramnios, placenta praevia, and abruptio placentae).
- Delivery before 37 weeks or after 42 weeks
- Neonatal weight was < 2.5 kg or>4.0 kg
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 |
|---|---|---|
| delayed cord clampingumbilical cord clamping more than 30 seconds after birth | Procedure or surgery | delayed cord clamping |
| early cord clampingumbilical cord clamping within 15 seconds after birth | Procedure or surgery | early cord clamping |
Primary outcome
neonatal cord acid-base status
Time frame: within the 15 minutes after delivery
arterial cord samples were analyzed within 15 min by blood gas analyzer
neonatal transcutaneous bilirubin level
Time frame: within the 1 to 3 days of age
The transcutaneous bilirubin was measured by the uniform TcB device three times a day
Number of infants with neonatal jaundice requiring phototherapy
Time frame: within the 1 to 3 days of age
the infants need phototherapy because of high bilirubin level
Number of infants with neonatal hyperbilirubinemia
Time frame: within the 1 to 3 days of age
the infants need phototherapy because of high bilirubin level
1 secondary outcome
neonatal initial blood glucose levels
Time frame: within the 30 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 39227873Zhao X, Xu A, Lu X, Chen B, Hua Y, Ma Y. Association of phthalates exposure and sex steroid hormones with late-onset preeclampsia: a case-control study. BMC Pregnancy Childbirth. 2024 Sep 3;24(1):577. doi: 10.1186/s12884-024-06793-5.
- Derived from this study: PubMed 35751710Pan S, Lu Q, Lan Y, Peng L, Yu X, Hua Y. Differential effects of delayed cord clamping on bilirubin levels in normal and diabetic pregnancies. Eur J Pediatr. 2022 Aug;181(8):3111-3117. doi: 10.1007/s00431-022-04536-2. Epub 2022 Jun 25.
- Derived from this study: PubMed 35232426Shao H, Lan Y, Qian Y, Chen R, Peng L, Hua Y, Wang X. Effect of later cord clamping on umbilical cord blood gas in term neonates of diabetic mothers: a randomized clinical trial. BMC Pediatr. 2022 Mar 1;22(1):111. doi: 10.1186/s12887-022-03170-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed cord clamping and early cord clamping in people with Gestational Diabetes Mellitus and Neonatal Hyperbilirubinemia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ying hua, doctorate (13676403165, wzfeyhy1015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal cord acid-base status (time frame: within the 15 minutes after delivery). The study lists 4 primary outcomes in all. 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 NCT04369313, which also lists 3 linked publications.
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 Mar 2021.