Preterm LaborNCT04554745
The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor
A study testing Ultrasound in people with Preterm Labor, run by Assiut University at 1 site in Egypt.
Trial summary
Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Aug 2022
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnant
- gestational age at 18 weeks
- previous vaginal or Cesarean section
Who cannot join
- twins pregnancy in their second birth
- previous preterm labor
- diabetic during the second pregnancy
- hypertensive during the second pregnancy
- cigarette use during the second pregnancy
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Assessment of Cervical Length and Thickness of Cesarean Section Scar as Predictors for Preterm Labor in Patients With Previous Cesarean Section
Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity.
Preterm is defined as babies born alive before completing 37 weeks of pregnancy.
Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.
- Conditions
- Preterm Labor
- Being tested
- Ultrasound
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
ultrasound assessment of pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Non-scared uterus of pregnant women | Other | Not described Receives: Radiation: Ultrasound |
| Scared uterus of pregnant women | Other | Not described Receives: Radiation: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preterm labor in both groups
Measured: 6 months
Secondary outcomes (2)
number of babies will enter the neonatal intensive care unit
Measured: 6 months
Gestational age at time of delivery
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 posted18 Sep 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
- Investigators
- Ahmed Abo Al Fadl Elsayed Mohammed, Asst.prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554745
- Sponsor's protocol ID
- Preterm labor and previous cs
- Status last verified
- Dec 2022
- First submitted
- 13 Sep 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu HT, Xu JJ, Lin J, Li C, Wu YT, Sheng JZ, Liu XM, Huang HF. Association between first caesarean delivery and adverse outcomes in subsequent pregnancy: a retrospective cohort study. BMC Pregnancy Childbirth. 2018 Jun 28;18(1):273. doi: 10.1186/s12884-018-1895-x.
PubMed 29954355Urquia ML. Is the association between previous caesarean section and preterm delivery causal? BJOG. 2020 Apr;127(5):618. doi: 10.1111/1471-0528.16099. Epub 2020 Feb 10. No abstract available.
PubMed 31953981Visser L, Slaager C, Kazemier BM, Rietveld AL, Oudijk MA, de Groot C, Mol BW, de Boer MA. Risk of preterm birth after prior term cesarean. BJOG. 2020 Apr;127(5):610-617. doi: 10.1111/1471-0528.16083. Epub 2020 Feb 24.
PubMed 31883402Wang M, Kirby A, Gibbs E, Gidaszewski B, Khajehei M, Chua SC. Risk of preterm birth in the subsequent pregnancy following caesarean section at full cervical dilatation compared with mid-cavity instrumental delivery. Aust N Z J Obstet Gynaecol. 2020 Jun;60(3):382-388. doi: 10.1111/ajo.13058. Epub 2019 Sep 12.
PubMed 31514230Williams CM, Asaolu I, Chavan NR, Williamson LH, Lewis AM, Beaven L, Ashford KB. Previous cesarean delivery associated with subsequent preterm birth in the United States. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:88-93. doi: 10.1016/j.ejogrb.2018.08.013. Epub 2018 Aug 11.
PubMed 30130688Yasseen Iii AS, Bassil K, Sprague A, Urquia M, Maguire JL. Late preterm birth and previous cesarean section: a population-based cohort study. J Matern Fetal Neonatal Med. 2019 Jul;32(14):2400-2407. doi: 10.1080/14767058.2018.1438397. Epub 2018 Feb 21.
PubMed 29415589Zhang N, Chen H, Xu Z, Wang B, Sun H, Hu Y. Pregnancy, Delivery, and Neonatal Outcomes of In Vitro Fertilization-Embryo Transfer in Patient with Previous Cesarean Scar. Med Sci Monit. 2016 Sep 16;22:3288-95. doi: 10.12659/msm.900581.
PubMed 27636504Zhang Y, Zhou J, Ma Y, Liu L, Xia Q, Fan D, Ai W. Mode of delivery and preterm birth in subsequent births: A systematic review and meta-analysis. PLoS One. 2019 Mar 14;14(3):e0213784. doi: 10.1371/journal.pone.0213784. eCollection 2019.
PubMed 30870524
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Cervical Length and Thickness of Cesarean Section Scar as Predictors for Preterm Labor in Patients With Previous Cesarean Section
- ClinicalTrials.gov ID
- NCT04554745
- Acronym / sponsor ID
- Preterm labor and previous cs
- Conditions
- Preterm Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Sep 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.
Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity.
Preterm is defined as babies born alive before completing 37 weeks of pregnancy.
Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-scared uterus of pregnant women | Other | Radiation: Ultrasound |
| Scared uterus of pregnant women | Other | Radiation: Ultrasound |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton pregnant
- gestational age at 18 weeks
- previous vaginal or Cesarean section
Key exclusion criteria (6 listed)
- twins pregnancy in their second birth
- previous preterm labor
- diabetic during the second pregnancy
- hypertensive during the second pregnancy
- cigarette use during the second 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 |
|---|---|---|
| Ultrasoundultrasound assessment of pregnant women | Radiation | Non-scared uterus of pregnant women, Scared uterus of pregnant women |
Primary outcome
Number of preterm labor in both groups
Time frame: 6 months
2 secondary outcomes
number of babies will enter the neonatal intensive care unit
Time frame: 6 months
Gestational age at time of delivery
Time frame: 6 months
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 13 Dec 2022.
- Background: PubMed 29954355Hu HT, Xu JJ, Lin J, Li C, Wu YT, Sheng JZ, Liu XM, Huang HF. Association between first caesarean delivery and adverse outcomes in subsequent pregnancy: a retrospective cohort study. BMC Pregnancy Childbirth. 2018 Jun 28;18(1):273. doi: 10.1186/s12884-018-1895-x.
- Background: PubMed 31953981Urquia ML. Is the association between previous caesarean section and preterm delivery causal? BJOG. 2020 Apr;127(5):618. doi: 10.1111/1471-0528.16099. Epub 2020 Feb 10. No abstract available.
- Background: PubMed 31883402Visser L, Slaager C, Kazemier BM, Rietveld AL, Oudijk MA, de Groot C, Mol BW, de Boer MA. Risk of preterm birth after prior term cesarean. BJOG. 2020 Apr;127(5):610-617. doi: 10.1111/1471-0528.16083. Epub 2020 Feb 24.
- Background: PubMed 31514230Wang M, Kirby A, Gibbs E, Gidaszewski B, Khajehei M, Chua SC. Risk of preterm birth in the subsequent pregnancy following caesarean section at full cervical dilatation compared with mid-cavity instrumental delivery. Aust N Z J Obstet Gynaecol. 2020 Jun;60(3):382-388. doi: 10.1111/ajo.13058. Epub 2019 Sep 12.
- Background: PubMed 30130688Williams CM, Asaolu I, Chavan NR, Williamson LH, Lewis AM, Beaven L, Ashford KB. Previous cesarean delivery associated with subsequent preterm birth in the United States. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:88-93. doi: 10.1016/j.ejogrb.2018.08.013. Epub 2018 Aug 11.
- Background: PubMed 29415589Yasseen Iii AS, Bassil K, Sprague A, Urquia M, Maguire JL. Late preterm birth and previous cesarean section: a population-based cohort study. J Matern Fetal Neonatal Med. 2019 Jul;32(14):2400-2407. doi: 10.1080/14767058.2018.1438397. Epub 2018 Feb 21.
- Background: PubMed 27636504Zhang N, Chen H, Xu Z, Wang B, Sun H, Hu Y. Pregnancy, Delivery, and Neonatal Outcomes of In Vitro Fertilization-Embryo Transfer in Patient with Previous Cesarean Scar. Med Sci Monit. 2016 Sep 16;22:3288-95. doi: 10.12659/msm.900581.
- Background: PubMed 30870524Zhang Y, Zhou J, Ma Y, Liu L, Xia Q, Fan D, Ai W. Mode of delivery and preterm birth in subsequent births: A systematic review and meta-analysis. PLoS One. 2019 Mar 14;14(3):e0213784. doi: 10.1371/journal.pone.0213784. eCollection 2019.
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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 Abo Al Fadl Elsayed Mohammed, Asst.prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Preterm Labor, run by Assiut 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 3 inclusion and 6 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 13 Dec 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?
Number of preterm labor in both groups (time frame: 6 months). 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 NCT04554745, which also lists 8 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 13 Dec 2022.