Impact of Maternity Napkins on the Incidence of Vaginal Infections in the Post-partum Period

NCT05806879 | Unknown

• 1 other identifier: 6367
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will compare the incidence of vaginal infections in the post-partum period in women using sanitary napkins, with women using their current methods of managing lochia. 350 women will be recruited from a health center present in Badin, Sindh, and will be randomized into an intervention or control group. The intervention group will receive maternity napkins while the control group will continue to use their current method of lochia management. Symptoms of vaginal infection and patient comfort with the method of lochia management will be assessed by a questionnaire administered by a research assistant via bi-weekly visits. A self -administered low vaginal swab will also be obtained at each visit.

Conditions

Vaginal Infection

Keywords

Maternal Mortality; Maternal Morbidity; Sanitary Napkin; Maternity Napkin

Outcome Measures

Primary Outcomes (1)

• Presence of Culture Positive Vaginal Infection

  Participants will perform a self-taken low vaginal swab (LVS) every 2 weeks (bi-weekly) for confirmation of vaginal infection. Self-taken LVS are a viable alternative to clinician-taken high vaginal swab (HVS) with comparable sensitivity for detecting infection. Growth of micro-organisms including: Gardnerella vaginalis, Mycoplasma hominis, Prevotella species, Mobiluncus species, Trichomonas vaginalis, Candida albicans, Candida krusei, Candida glabrata will constitute positive culture growth.

  4.5 months

Secondary Outcomes (2)

• Symptoms of Vaginal Infection

  4.5 months

• Patient Comfort based on Means of Lochia Management

  4.5 months

Study Arms (2)

Maternity Napkins

EXPERIMENTAL

The intervention group will receive maternity napkins to manage postpartum lochia with the following specifications: * Length is 230-240mm, to be able to provide adequate coverage. * Width is 150-155mm with wings. * Thickness is 3-5mm. * The maternity napkin is curved to prevent leakage on the sides, has wings for secure attachment to the underwear and able to absorb 30-40 ml per minute

Other: Maternity Napkin

Continued Use of Current Methods

NO INTERVENTION

The control group will continue to use their current indigenous methods for managing postpartum lochia.

Interventions

Maternity Napkin OTHER

Use of maternity napkin with the following specifications (followed for 4.5 months) * Length is 230-240mm, to be able to provide adequate coverage. * Width is 150-155mm with wings. * Thickness is 3-5mm. * The maternity napkin is curved to prevent leakage on the sides, has wings for secure attachment to the underwear and able to absorb 30-40 ml per minute.

Maternity Napkins

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women above the age of 18 years who are undergoing delivery (spontaneous, induced, or assisted vaginal delivery and caesarean delivery) at the Maternal and Child Health Center
• Women between 1-3 days of the postpartum period
• Women who would not otherwise use sanitary napkins during the postpartum period

You may not qualify if:

• Women who currently already use sanitary napkins to manage lochia or who have undergone a caesarean (C-section) delivery will be excluded from this study.

Sponsors & Collaborators

• Aga Khan University: lead

Related Publications (11)

• Ali TS, Fikree FF, Rahbar MH, Mahmud S. Frequency and determinants of vaginal infection in postpartum period: a cross-sectional survey from low socioeconomic settlements, Karachi, Pakistan. J Pak Med Assoc. 2006 Mar;56(3):99-103.

  PMID: 16696506 BACKGROUND

• Ghani N, Rukanuddin RJ, Ali TS. Prevalence and factors associated with postpartum vaginal infection in the Khyber Agency federally administered tribal areas, Pakistan. J Pak Med Assoc. 2007 Jul;57(7):363-7.

  PMID: 17867261 BACKGROUND

• Boushra M, Carlson K, Rahman O. Postpartum Infection. 2025 Jul 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560804/

  PMID: 32809639 BACKGROUND

• Ali TS, Sami N, Khuwaja AK. Are unhygienic practices during the menstrual, partum and postpartum periods risk factors for secondary infertility? J Health Popul Nutr. 2007 Jun;25(2):189-94.

  PMID: 17985820 BACKGROUND

• Chauhan G, Tadi P. Physiology, Postpartum Changes. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555904/

  PMID: 32310364 BACKGROUND

• Sami N, Ali TS, Wasim S, Saleem S. Risk factors for secondary infertility among women in Karachi, Pakistan. PLoS One. 2012;7(4):e35828. doi: 10.1371/journal.pone.0035828. Epub 2012 Apr 27.

  PMID: 22558233 BACKGROUND

• Shamshad, Shamsher S, Rauf B. Puerperal sepsis--still a major threat for parturient. J Ayub Med Coll Abbottabad. 2010 Jul-Sep;22(3):18-21.

  PMID: 22338409 BACKGROUND

• Ely JW, Rijhsinghani A, Bowdler NC, Dawson JD. The association between manual removal of the placenta and postpartum endometritis following vaginal delivery. Obstet Gynecol. 1995 Dec;86(6):1002-6. doi: 10.1016/0029-7844(95)00327-n.

  PMID: 7501321 BACKGROUND

• Fikree FF, Ali T, Durocher JM, Rahbar MH. Health service utilization for perceived postpartum morbidity among poor women living in Karachi. Soc Sci Med. 2004 Aug;59(4):681-94. doi: 10.1016/j.socscimed.2003.11.034.

  PMID: 15177827 BACKGROUND

• Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15.

  PMID: 21524046 BACKGROUND

• Barnes P, Vieira R, Harwood J, Chauhan M. Self-taken vaginal swabs versus clinician-taken for detection of candida and bacterial vaginosis: a case-control study in primary care. Br J Gen Pract. 2017 Dec;67(665):e824-e829. doi: 10.3399/bjgp17X693629.

  PMID: 29158246 BACKGROUND

Related Links

• Adika YVO, Apiyanteide JFA, Ologidi PW, Ekpo KE. Perception and behaviour on use of sanitary pads during menstruation among adolescent school girls in Bayelsa State , Nigeria. Adv Appl Sci Res \[Internet\]. 2011;2(6):9-15.
• Pakistan Maternal Mortality Survey 2019

MeSH Terms

Conditions

Vaginitis; Maternal Death

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants undergoing delivery at the maternal and child health centre will be randomized into an intervention and control group using a random number generator. The ratio of exposed to unexposed sample will be 1:1. The participants will be followed for 42 days via bi-weekly visits by research assistants.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 10, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share