NCT04554745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

September 13, 2020

Last Update Submit

December 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of preterm labor in both groups

    6 months

Secondary Outcomes (2)

  • number of babies will enter the neonatal intensive care unit

    6 months

  • Gestational age at time of delivery

    6 months

Study Arms (2)

Non-scared uterus of pregnant women

OTHER
Radiation: Ultrasound

Scared uterus of pregnant women

OTHER
Radiation: Ultrasound

Interventions

UltrasoundRADIATION

ultrasound assessment of pregnant women

Non-scared uterus of pregnant womenScared uterus of pregnant women

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amr

Asyut, 71111, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 29954355BACKGROUND
  • 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.

    PMID: 31953981BACKGROUND
  • 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.

    PMID: 31883402BACKGROUND
  • 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.

    PMID: 31514230BACKGROUND
  • 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.

    PMID: 30130688BACKGROUND
  • 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.

    PMID: 29415589BACKGROUND
  • 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.

    PMID: 27636504BACKGROUND
  • 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.

    PMID: 30870524BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Ahmed Abo Al Fadl Elsayed Mohammed, Asst.prof

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 18, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

August 1, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations