Neonatal OutcomeNCT03451864
Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
An observational study of Neonatal Outcome, run by Cairo University at 1 site in Egypt.
Trial summary
Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Neonatal Outcome
- What is being tested?
- Vaginal delivery and Cesarean Section
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2016to 24 Feb 2018
- Phase
- Observational
- 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
Study population: 88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0 years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean section
Who may be able to join
- Healthy women Term pregnancy
Who cannot join
- any chronic illness as chronic hypertension or pregestational diabetes pregnancy-related illnesses as preeclampsia, gestational diabetes multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA
Read the detailed description
Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA.Maternal 25 (OH) vitamin D measurement: Blood samples for determination of serum 25 (OH) vitamin D were collected by venipuncture and processed as follows: 3 mL blood were collected into plain tubes and allowed to clot for 30 minutes, then it was centrifuged at 1500 round per minute for 15 minutes at room temperature and the serum was separated into clean, properly labeled tubes and stored at ≤ -20°C till assay. Serum 25 (OH) vitamin D level was assessed by Enzyme-Linked ImmunoSorbent Assay (ELISA) using DRG 25-OH Vitamin D (total) ELISA (DRG International, Inc., USA) according to manufacturer's instructions. Vitamin D deficiency is defined by 25(OH) D levels less than 20 ng/d
- Conditions
- Neonatal Outcome
- Being tested
- Vaginal delivery, Cesarean Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal deliveryProcedure or surgery
classic vaginal delivery
Cesarean SectionProcedure or surgery
routine lower segment cesarean scetion
| Study group | Role | What they receive |
|---|---|---|
| Deficient Vit D | Mothers with serum 25(OH) D levels less than 20 ng/dl Receives: Procedure: Vaginal delivery; Procedure: Cesarean Section | |
| Normal vit D | Mothers with serum 25(OH) D levels more than 20 ng/dl Receives: Procedure: Vaginal delivery; Procedure: Cesarean Section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal intensive care unit admission
Admission of the neonate to NICU
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Sep 2016
- Primary completion1 Feb 2018
- Study completion24 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal OutcomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451864
- Sponsor's protocol ID
- 29
- Status last verified
- Feb 2018
- First submitted
- 25 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
- ClinicalTrials.gov ID
- NCT03451864
- Acronym / sponsor ID
- 29
- Conditions
- Neonatal Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 2 Mar 2018 (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.
Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA
Detailed description
Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study. Maternal serum 25-OHD was measured by ELISA.Maternal 25 (OH) vitamin D measurement: Blood samples for determination of serum 25 (OH) vitamin D were collected by venipuncture and processed as follows: 3 mL blood were collected into plain tubes and allowed to clot for 30 minutes, then it was centrifuged at 1500 round per minute for 15 minutes at room temperature and the serum was separated into clean, properly labeled tubes and stored at ≤ -20°C till assay. Serum 25 (OH) vitamin D level was assessed by Enzyme-Linked ImmunoSorbent Assay (ELISA) using DRG 25-OH Vitamin D (total) ELISA (DRG International, Inc., USA) according to manufacturer's instructions. Vitamin D deficiency is defined by 25(OH) D levels less than 20 ng/d
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deficient Vit D | – | Procedure: Vaginal delivery, Procedure: Cesarean SectionMothers with serum 25(OH) D levels less than 20 ng/dl |
| Normal vit D | – | Procedure: Vaginal delivery, Procedure: Cesarean SectionMothers with serum 25(OH) D levels more than 20 ng/dl |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0 years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean section
Key inclusion criteria (1 listed)
- Healthy women Term pregnancy
Key exclusion criteria (1 listed)
- any chronic illness as chronic hypertension or pregestational diabetes pregnancy-related illnesses as preeclampsia, gestational diabetes multiple pregnancy
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 |
|---|---|---|
| Vaginal deliveryclassic vaginal delivery | Procedure or surgery | Deficient Vit D, Normal vit D |
| Cesarean Sectionroutine lower segment cesarean scetion | Procedure or surgery | Deficient Vit D, Normal vit D |
Primary outcome
Neonatal intensive care unit admission
Time frame: 24 hours after delivery
Admission of the neonate to NICU
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 2 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Outcome, 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 1 inclusion and 1 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 2 Mar 2018. 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?
Neonatal intensive care unit admission (time frame: 24 hours after delivery). 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 2 Mar 2018.