Association of Urinary Tract Infection With Preeclampsia During Pregnancy

NCT06962644 | Recruiting

• 1 other identifier: TrialUTI
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract infections (UTIs) are a major clinical issue, especially in pregnant women, due to physiological changes that increase susceptibility. If untreated, UTIs can lead to severe complications like preterm labor and low birth weight. Preeclampsia, a hypertensive disorder affecting 0.2-9.2% of pregnancies, is another leading cause of maternal and fetal complications. The relationship between UTIs and preeclampsia remains controversial, with some studies suggesting an association while others show conflicting results. Research gaps highlight the need for region-specific studies, particularly in Pakistan, where both conditions contribute significantly to maternal and neonatal morbidity. This study aims to investigate the association between UTIs and preeclampsia in pregnant women in Pakistan. It will use a cohort design, enrolling 160 patients (80 with UTIs, 80 without) from the Obstetrics Department of PAF Hospital, Islamabad. Participants will be followed until delivery, with preeclampsia diagnosed based on blood pressure and proteinuria criteria. Data will be analyzed using SPSS to calculate relative risk (RR), with statistical significance set at RR \>1 and p ≤ 0.05. The findings could help improve prenatal care and reduce adverse outcomes in high-risk populations.

Conditions

Urinary Tract Infection (Diagnosis); Preeclampsia

Keywords

Preeclampsia; Pregnancy; Urinary tract infection; Term Birth

Outcome Measures

Primary Outcomes (1)

• Preeclampsia

  It will be defined as BP \>140/90 mmHg on minimum two occasions after 20 weeks of pregnancy alongside presence of proteinuria (≥300 mg/day or at least 1+ dipstick testing or spot urine protein/creatinine ratio of ≥30 mg/mmol).

  37 weeks of pregnancy

Study Arms (2)

UTI exposed

Patients suffering from UTI as per protocol

Other: Preeclampsia developed

UTI non exposed

Patients having no clinical and laboratory evidence of UTI

Other: Preeclampsia developed

Interventions

Preeclampsia developed OTHER

Preecalmpsia will be defined as per study protocol

Also known as: preeclampsia not developed

UTI exposed; UTI non exposed

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with gestational amenorrhea coming for routine antenatal checkup

You may qualify if:

• Patients attending OPD for routine antenatal checkup
• Patients diagnosed with UTI as per operational definitions
• Gestational age greater than 20 weeks as per LMP
• Age between 18 to 35 years

You may not qualify if:

• History of medical conditions such as:
• Diabetes mellitus
• Chronic hypertension
• Chronic liver or kidney diseases
• Chronic pulmonary conditions
• History of urological surgical interventions in the past 3 months
• History of renal transplants
• Patients on immunosuppressive therapy
• History of comorbid conditions including:
• Diabetes mellitus
• Gestational diabetes mellitus
• Hypertension
• Chronic hepatic diseases
• Chronic liver diseases
• Chronic pulmonary diseases

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

PAF Hospital, Islamabad

Islamabad, 45100, Pakistan

RECRUITING

Related Publications (10)

• Johnson CY, Rocheleau CM, Howley MM, Chiu SK, Arnold KE, Ailes EC. Characteristics of Women with Urinary Tract Infection in Pregnancy. J Womens Health (Larchmt). 2021 Nov;30(11):1556-1564. doi: 10.1089/jwh.2020.8946. Epub 2021 Sep 1.

  PMID: 34491115 BACKGROUND

• Haghdoost S, Pazandeh F, Khabazkhoob M, Bhroozi R. Assocoation Between Sexual and Genital Hygiene Habits with the Urinary Tact Infectin During Pregnancy: A Case-Control Study. International Journal of Women's Health and Reproduction Sciences. 2020;8(2):158-63.

  BACKGROUND

• Radu VD, Vicoveanu P, Carauleanu A, Adam AM, Melinte-Popescu AS, Adam G, Onofrei P, Socolov D, Vasilache IA, Harabor A, Melinte-Popescu M, Scripcariu IS, Mihalceanu E, Stuparu-Cretu M, Harabor V. Pregnancy Outcomes in Patients with Urosepsis and Uncomplicated Urinary Tract Infections-A Retrospective Study. Medicina (Kaunas). 2023 Dec 7;59(12):2129. doi: 10.3390/medicina59122129.

  PMID: 38138232 BACKGROUND

• Kaduma J, Seni J, Chuma C, Kirita R, Mujuni F, Mushi MF, van der Meer F, Mshana SE. Urinary Tract Infections and Preeclampsia among Pregnant Women Attending Two Hospitals in Mwanza City, Tanzania: A 1:2 Matched Case-Control Study. Biomed Res Int. 2019 Mar 27;2019:3937812. doi: 10.1155/2019/3937812. eCollection 2019.

  PMID: 31032344 BACKGROUND

• Stitterich N, Shepherd J, Koroma MM, Theuring S. Risk factors for preeclampsia and eclampsia at a main referral maternity hospital in Freetown, Sierra Leone: a case-control study. BMC Pregnancy Childbirth. 2021 Jun 2;21(1):413. doi: 10.1186/s12884-021-03874-7.

  PMID: 34078312 BACKGROUND

• Yaqub U, Khattak SN, Khattak MI, Akram U, Gardezi A, Mansoor K. Maternal Urinary Tract Infection and Risk of Preeclampsia: A Cross Sectional Comparative Study. J Soc Obstet Gynaecol Pak. 2022;12(1):1-6.

  BACKGROUND

• Taghavi Zahedkalaei A, Kazemi M, Zolfaghari P, Rashidan M, Sohrabi MB. Association Between Urinary Tract Infection in the First Trimester and Risk of Preeclampsia: A Case-Control Study. Int J Womens Health. 2020 Jul 10;12:521-526. doi: 10.2147/IJWH.S256943. eCollection 2020.

  PMID: 32765118 BACKGROUND

• Bajwa FA, Sultana N, Sadaqat A, Riaz A, Sikandar MZ. Factors contributing to preterm birth in patients presenting at tertiary care hospitals in Punjab. J Pak Med Assoc. 2024 Mar;74(3):504-508. doi: 10.47391/JPMA.9474.

  PMID: 38591287 BACKGROUND

• Getaneh T, Negesse A, Dessie G, Desta M, Tigabu A. Prevalence of Urinary Tract Infection and Its Associated Factors among Pregnant Women in Ethiopia: A Systematic Review and Meta-Analysis. Biomed Res Int. 2021 Dec 1;2021:6551526. doi: 10.1155/2021/6551526. eCollection 2021.

  PMID: 34901276 BACKGROUND

• Ghouri F, Hollywood A, Ryan K. Urinary tract infections and antibiotic use in pregnancy - qualitative analysis of online forum content. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):289. doi: 10.1186/s12884-019-2451-z.

  PMID: 31409404 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Disease; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications

Central Study Contacts

Wajiha Fatima Resident, MBBS, FCPS (I)

CONTACT

+923338747575; mwajeeha52@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: January 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)