The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor

NCT ID: NCT04554745

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-scared uterus of pregnant women

Group Type OTHER

Ultrasound

Intervention Type RADIATION

ultrasound assessment of pregnant women

Scared uterus of pregnant women

Group Type OTHER

Ultrasound

Intervention Type RADIATION

ultrasound assessment of pregnant women

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

ultrasound assessment of pregnant women

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. singleton pregnant
2. gestational age at 18 weeks
3. previous vaginal or Cesarean section

Exclusion Criteria

1. twins pregnancy in their second birth
2. previous preterm labor
3. diabetic during the second pregnancy
4. hypertensive during the second pregnancy
5. cigarette use during the second pregnancy
6. congenital anomalies
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Khairy Ali

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Abo Al Fadl Elsayed Mohammed, Asst.prof

Role: STUDY_DIRECTOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amr

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29954355 (View on PubMed)

Urquia 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.

Reference Type BACKGROUND
PMID: 31953981 (View on PubMed)

Visser 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.

Reference Type BACKGROUND
PMID: 31883402 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 31514230 (View on PubMed)

Williams 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.

Reference Type BACKGROUND
PMID: 30130688 (View on PubMed)

Yasseen 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.

Reference Type BACKGROUND
PMID: 29415589 (View on PubMed)

Zhang 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.

Reference Type BACKGROUND
PMID: 27636504 (View on PubMed)

Zhang 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.

Reference Type BACKGROUND
PMID: 30870524 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Preterm labor and previous cs

Identifier Type: -

Identifier Source: org_study_id