Neonatal SEPSISNCT03590483
Outcomes in Spontaneous and ART Twin Pregnancies
An observational study of Neonatal SEPSIS and Perinatal Mortality, run by Hawler Medical University at 1 site in Iraq.
Trial summary
During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility. this was associated with increased the rate of twin pregnancies Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal SEPSIS, Perinatal Mortality, Maternal Morbidity
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2016to 31 Dec 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twin delivery was identified when coming to outpatient clinic \& labour ward into two groups, first group iatrogenic conceived twins (either ART, or medical ovulation induction mainly clomiphene citrate and gonadotrophins).The second group is a twin pregnancy who conceived naturally . Demographic characters, maternal and neonatal outcomes were compared in both groups
Who may be able to join
- Twin delivered >24-week gestational age
- weight ≥ 500g
- Diachronic diamniotic twins.
Who cannot join
- Intrauterine fetal deaths
- Higher-order multiple pregnancies
- Deliveries complicated by early vanishing fetuses
- Twin pregnancies reduced to singleton
- Triple pregnancy reduced to twin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal and Perinatal Outcomes in Spontaneous Twins Versus Twins Conceived by Ovulation Induction and Assisted Reproductive Techniques: A Cross Section Study Within One Year
During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility.
this was associated with increased the rate of twin pregnancies
Read the detailed description
Twin pregnancies are associated with an increased risk of maternal mortality \& morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy.
The heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes.
Evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (ART) compared with those naturally conceived (NC) is conflicting, A 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .
- Conditions
- Neonatal SEPSIS, Perinatal Mortality, Maternal Morbidity
- Keywords
- Twins, ART, Induction of Ovulation, Perinatal mortality
- Medical subject headings
- Neonatal Sepsis, Perinatal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal diabetes using glucose tolerance test
The diagnosis of GDM was based a fasting plasma glucose level of ≥5.6 mmol/L with 2 h plasma glucose level of ≥7.8 mmol/L
Measured: up to 7 days postpartum
Hypertension during pregnancy and preeclampsia diagnosed using ACOG guideline a) weight in kilogram b) Apgar score in first and 10th minutes c)Admission to neonatal intensive acre unit measured in days
Systolic and diastolic blood pressure equal or more than140/90 mm Hg measured on two or more occasions after 20 weeks of gestation in previously normotensive women, with or without proteinuria (proteinuria of >100 mg/dL by urine analysis, or >300 mg/24 h)
Measured: up to 1 week postpartum
Maternal anemia using WHO criteria
Hemoglobin level less than 11gm/dl
Measured: up to 1 week
Postpartum hemorrhage
Bleeding from genital tract of 500 mL or more vaginally
Measured: up to 1 week
Neonatal weight in kilogram
categorized as extreme low birth weight (LBW) for <1000 g, very LBW for 1000-1500 g, LBW for 1500-2500 g, and normal birth weight for >2500 g
Measured: up to 7 days
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score
Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
Measured: first and fifth minute of life
Admission to neonatal care unit in days
Fetal care unit
Measured: up to 7 days
Secondary outcomes (1)
Maternal mode of delivery
Cesarean section or vaginal delivery
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Nov 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Alalaf, Hawler Medical University
- Investigators
- Diana Y. Rashid, Principal investigator, Maternity Teaching HospitalShahla K. Alalaf, Study director, Hawler Medical University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590483
- Sponsor's protocol ID
- SAlalaf
- Status last verified
- Jul 2018
- First submitted
- 16 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Perinatal Outcomes in Spontaneous Twins Versus Twins Conceived by Ovulation Induction and Assisted Reproductive Techniques: A Cross Section Study Within One Year
- ClinicalTrials.gov ID
- NCT03590483
- Acronym / sponsor ID
- SAlalaf
- Conditions
- Neonatal SEPSIS, Perinatal Mortality, Maternal Morbidity
- Keywords
- Twins, ART, Induction of Ovulation, Perinatal mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Jul 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.
During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility.
this was associated with increased the rate of twin pregnancies
Detailed description
Twin pregnancies are associated with an increased risk of maternal mortality \& morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy.
The heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes.
Evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (ART) compared with those naturally conceived (NC) is conflicting, A 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twin delivery was identified when coming to outpatient clinic \& labour ward into two groups, first group iatrogenic conceived twins (either ART, or medical ovulation induction mainly clomiphene citrate and gonadotrophins).The second group is a twin pregnancy who conceived naturally . Demographic characters, maternal and neonatal outcomes were compared in both groups
Key inclusion criteria (3 listed)
- Twin delivered >24-week gestational age
- weight ≥ 500g
- Diachronic diamniotic twins.
Key exclusion criteria (5 listed)
- Intrauterine fetal deaths
- Higher-order multiple pregnancies
- Deliveries complicated by early vanishing fetuses
- Twin pregnancies reduced to singleton
- Triple pregnancy reduced to twin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal diabetes using glucose tolerance test
Time frame: up to 7 days postpartum
The diagnosis of GDM was based a fasting plasma glucose level of ≥5.6 mmol/L with 2 h plasma glucose level of ≥7.8 mmol/L
Hypertension during pregnancy and preeclampsia diagnosed using ACOG guideline a) weight in kilogram b) Apgar score in first and 10th minutes c)Admission to neonatal intensive acre unit measured in days
Time frame: up to 1 week postpartum
Systolic and diastolic blood pressure equal or more than140/90 mm Hg measured on two or more occasions after 20 weeks of gestation in previously normotensive women, with or without proteinuria (proteinuria of >100 mg/dL by urine analysis, or >300 mg/24 h)
Maternal anemia using WHO criteria
Time frame: up to 1 week
Hemoglobin level less than 11gm/dl
Postpartum hemorrhage
Time frame: up to 1 week
Bleeding from genital tract of 500 mL or more vaginally
Neonatal weight in kilogram
Time frame: up to 7 days
categorized as extreme low birth weight (LBW) for <1000 g, very LBW for 1000-1500 g, LBW for 1500-2500 g, and normal birth weight for >2500 g
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score
Time frame: first and fifth minute of life
Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
Admission to neonatal care unit in days
Time frame: up to 7 days
Fetal care unit
1 secondary outcome
Maternal mode of delivery
Time frame: during labor
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 Jul 2018.
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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.
Diana Y. Rashid principal investigator
Maternity Teaching Hospital
Shahla K. Alalaf study director
Hawler Medical University, College of Medicine
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 SEPSIS and Perinatal Mortality, run by Hawler Medical University at 1 site in Iraq.
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 5 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 Jul 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 Iraq. 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?
Maternal diabetes using glucose tolerance test (time frame: up to 7 days postpartum). The study lists 7 primary outcomes in all. 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 23 Jul 2018.