Vaginal Infection Clinical Trial
Official title:
The Impact of Using Maternity Napkins on the Incidence of Vaginal Infections in the Post-partum Period: A Randomized Controlled Trial
NCT number | NCT05806879 |
Other study ID # | 6367 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2023 |
Est. completion date | June 2024 |
Verified date | April 2023 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 350 |
Est. completion date | June 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Aga Khan University |
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. Erratum In: J Pak Med Assoc. 2006 Jul;56(7):344. — View Citation
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. — View Citation
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. — View Citation
Boushra M, Rahman O. Postpartum Infection. 2022 Jul 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560804/ — View Citation
Chauhan G, Tadi P. Physiology, Postpartum Changes. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555904/ — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Symptoms of Vaginal Infection | Itching, perceived foul smelling vaginal discharge, fever, and lower abdominal pain will be inquired during the follow up visit every 2 weeks (bi-weekly) by the research assistant using an adapted questionnaire. The questionnaire will be validated in our study population before administration. The questionnaires have been developed in English and will be translated to Sindhi, the native language. | 4.5 months | |
Secondary | Patient Comfort based on Means of Lochia Management | Comfort of the patient will be inquired and recorded during the follow-up visit every 2 weeks (bi-weekly) using an adapted Likert scale, with 1 being not comfortable, and 5 being very comfortable. Comfort will be assessed based on three components including comfort, perception and behavior. The questionnaires have been developed in English and will be translated to Sindhi, the native language, and validated in the study population before administration to the control and intervention group. | 4.5 months |
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