Fetal Growth RetardationNCT05176041
SLE Therapy Changes in Pregnancy and Relation to Pregnancy Outcome
An observational study of Fetal Growth Retardation, run by University of Jordan.
Trial summary
to review the changes to SLE medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Naser Al-Husban
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2021
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with SLE
Who may be able to join
- confirmed SLE
- completed data
Who cannot join
- doubtful diagnosis of SLE
- those with missing data
- those with medications other than prednisolone, HCQ and anticoagulants
- those with multifetal pregnancies
- those patients with confirmed other medical diseases including diabetes mellitus, hypertension, thyroid disorders, anti-phospholipid antibody syndrome (APAS), cardiac disease
- those with confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE)
- those with associated hematological diseases including SLE-associated thrombocytopenia.
About this study
Official title: Therapeutic Alterations of Systemic Lupus Erythematosus (SLE) Patients in Pregnancy and Feto-maternal Outcomes; Retrospective Cohort Study
to review the changes to SLE medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease.
Read the detailed description
This was a retrospective study of pregnancies in SLE patients. These patients had confirmed SLE diagnosis according to the American College of Rheumatology (ACR) criteria (5). The diagnosis of SLE was confirmed by consultant rheumatologist. These patients were followed up by consultant rheumatologist and obstetrician. The pregnancies' data were curated using the patients' medical files and notes, both paper-based and electronic, antenatal records, rheumatology and hematology clinic notes in addition to delivery and postpartum records. These data were collected including ID numbers, ages, duration of the SLE, their SLE medications before the pregnancy (names, doses and frequency) and whether the SLE was active or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease activity index (SLEDAI) score. the investigators studied Hydroxychloroquine (HCQ), prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and low molecular weight heparins (LMWH) Enoxaparin 40 mg subcutaneously once daily) as these were the most commonly used medications. The use of these medications in the different pregnancy periods were noted and analyzed (BPG, before pregnancy; DPG, during pregnancy; PG, pregnancy; PP, post-partum). Changes in these medications were also recorded. The data was then analyzed to find out the rates of changes and discontinuation. The postpartum period was also studied similarly. The investigators correlated these alterations to the following feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction (IUGR) and intra-uterine fetal death (IUFD). The 6 months-pre-conceptual SLEDAI score was recorded and investigated in relation to the above mentioned feto-maternal outcomes and postpartum relapse. We divided the pregnancies into 2 groups; Group A, inactive SLE and SLEDAI score of 0-3; Group b, active SLE and SLEDAI score of 4-24.
- Conditions
- Fetal Growth Retardation
- Being tested
- Naser Al-Husban
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naser Al-HusbanOther
observation
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal growth restriction
the effects of changes in SLE medications in pregnancy periods on final new born weight in grams.
Measured: 8 months
development of pre-eclampsia
SLE medication change and its effects on risk of pre-eclampsia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startSep 2016
- Primary completionNov 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, University of Jordan
- Investigators
- Naser Al-Husban, A. Professor, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176041
- Sponsor's protocol ID
- the Jordan University hospital
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Alterations of Systemic Lupus Erythematosus (SLE) Patients in Pregnancy and Feto-maternal Outcomes; Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05176041
- Acronym / sponsor ID
- the Jordan University hospital
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 4 Jan 2022 (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 review the changes to SLE medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease.
Detailed description
This was a retrospective study of pregnancies in SLE patients. These patients had confirmed SLE diagnosis according to the American College of Rheumatology (ACR) criteria (5). The diagnosis of SLE was confirmed by consultant rheumatologist. These patients were followed up by consultant rheumatologist and obstetrician. The pregnancies' data were curated using the patients' medical files and notes, both paper-based and electronic, antenatal records, rheumatology and hematology clinic notes in addition to delivery and postpartum records. These data were collected including ID numbers, ages, duration of the SLE, their SLE medications before the pregnancy (names, doses and frequency) and whether the SLE was active or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease activity index (SLEDAI) score. the investigators studied Hydroxychloroquine (HCQ), prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and low molecular weight heparins (LMWH) Enoxaparin 40 mg subcutaneously once daily) as these were the most commonly used medications. The use of these medications in the different pregnancy periods were noted and analyzed (BPG, before pregnancy; DPG, during pregnancy; PG, pregnancy; PP, post-partum). Changes in these medications were also recorded. The data was then analyzed to find out the rates of changes and discontinuation. The postpartum period was also studied similarly. The investigators correlated these alterations to the following feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction (IUGR) and intra-uterine fetal death (IUFD). The 6 months-pre-conceptual SLEDAI score was recorded and investigated in relation to the above mentioned feto-maternal outcomes and postpartum relapse. We divided the pregnancies into 2 groups; Group A, inactive SLE and SLEDAI score of 0-3; Group b, active SLE and SLEDAI score of 4-24.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with SLE
Key inclusion criteria (2 listed)
- confirmed SLE
- completed data
Key exclusion criteria (7 listed)
- doubtful diagnosis of SLE
- those with missing data
- those with medications other than prednisolone, HCQ and anticoagulants
- those with multifetal pregnancies
- those patients with confirmed other medical diseases including diabetes mellitus, hypertension, thyroid disorders, anti-phospholipid antibody syndrome (APAS), cardiac disease
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 |
|---|---|---|
| Naser Al-Husbanobservation | Other | – |
Primary outcome
fetal growth restriction
Time frame: 8 months
the effects of changes in SLE medications in pregnancy periods on final new born weight in grams.
development of pre-eclampsia
Time frame: 6 months
SLE medication change and its effects on risk of pre-eclampsia
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 4 Jan 2022.
- Individual participant dataSharing planned: Undecided. available on reasonable request
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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.
Naser Al-Husban, A. Professor principal investigator
University of Jordan
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by University of Jordan.
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 2 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
fetal growth restriction (time frame: 8 months). The study lists 2 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 4 Jan 2022.