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

Primary Purpose

Preterm Labor

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ultrasound

About this trial

This is an interventional diagnostic trial for Preterm Labor

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

singleton pregnant
gestational age at 18 weeks
previous vaginal or Cesarean section

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Non-scared uterus of pregnant women

Scared uterus of pregnant women

Arm Description

Outcomes

Primary Outcome Measures

Number of preterm labor in both groups

Secondary Outcome Measures

number of babies will enter the neonatal intensive care unit

Gestational age at time of delivery

Full Information

NCT ID

NCT04554745

First Posted

September 13, 2020

Last Updated

December 10, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04554745

Brief Title

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

Official Title

The Assessment of Cervical Length and Thickness of Cesarean Section Scar as Predictors for Preterm Labor in Patients With Previous Cesarean Section

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Labor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-scared uterus of pregnant women

Arm Type

Other

Arm Title

Scared uterus of pregnant women

Arm Type

Other

Intervention Type

Radiation

Intervention Name(s)

Ultrasound

Intervention Description

ultrasound assessment of pregnant women

Primary Outcome Measure Information:

Title

Number of preterm labor in both groups

Time Frame

6 months

Secondary Outcome Measure Information:

Title

number of babies will enter the neonatal intensive care unit

Time Frame

6 months

Title

Gestational age at time of delivery

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: singleton pregnant gestational age at 18 weeks previous vaginal or Cesarean section Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Abo Al Fadl Elsayed Mohammed, Asst.prof

Organizational Affiliation

Assiut University

Official's Role

Study Director

Facility Information:

Facility Name

Amr

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

29954355

Citation

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.

Results Reference

background

PubMed Identifier

31953981

Citation

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.

Results Reference

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PubMed Identifier

31883402

Citation

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.

Results Reference

background

PubMed Identifier

31514230

Citation

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.

Results Reference

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PubMed Identifier

30130688

Citation

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.

Results Reference

background

PubMed Identifier

29415589

Citation

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.

Results Reference

background

PubMed Identifier

27636504

Citation

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.

Results Reference

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PubMed Identifier

30870524

Citation

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.

Results Reference

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

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