Effects of Second-hand Smoke on a Pregnant Woman

NCT04488276 | Completed DMC

• 1 other identifier: AC19107
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

More than 40% of all pregnant women in Pakistan are exposed to second-hand smoke - causing approximately 17,000 still births in a year. In Pakistan only 1% of still births are attributed to women actively smoking during pregnancy, but for second-hand smoke the figure is 7%, largely due to the high numbers of pregnant women exposed to tobacco smoke in the home. Negative effects of Second-hand smoking (SHS) on maternal and fetal health are well established. In low and middle-income countries (LMICs) smoking inside the house is largely unrestricted adversely affecting pregnant women by exposure to SHS. SHS exposure in non-smoking pregnant women has increased the risk of stillbirth and congenital malformation along with behavioural and cognitive issues in children. Partner's support during pregnancy is important for developing a better maternal health. Therefore, a phenomenological research approach is appropriate for describing the essence of experience in terms of affective and emotional aspects. Phenomenology is an approach of creating phenomenological knowledge in a situation by describing implicit meaning of experience. The investigators therefore propose an epistemological approach of phenomenology.

Conditions

Post Partum; Pregnancy Related

Keywords

Second hand smoke; Smoking fathers; Pregnant women; Post partum women

Outcome Measures

Primary Outcomes (2)

• Proportion of pregnant women exposed to SHS

  In depth interviews will be conducted using a semi structured interview guide

  six months

• proportion of smoker husbands with adequate knowledge of effects of SHS on pregnancy

  In depth interviews will be conducted with assess the knowledge using a semi structrured interview guide

  six months

Study Arms (2)

Pregnant women

Non smoking pregnant and post-partum women

Other: In-depth interviews

Smoking fathers

Expectant or new fathers who smoke

Other: In-depth interviews

Interventions

In-depth interviews OTHER

In-depth interviews will be conducted to understand how smoking partners of pregnant women perceive risks and behaviors related to SHS exposure and how can it be altered to decrease exposure of pregnant women to SHS. These will be conducted in peri-urban slums and rural settings of Rawalpindi district with expectant or new father who smoke and pregnant or new mothers exposed to SHS. Interview guide will be developed deductively as a result of the systematic review and will be piloted before its actual use. Trained interviewer will conduct in-depth interview using semi-structured interview guide and will record it with consent from respondents. This data will be transcribed and translated and coded by team of two researchers.

Pregnant women; Smoking fathers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Number of Participants: Sample size will be based on the point of theoretical saturation, although at least 25-30 interviews will be conducted with fathers who are smokers and 10-15 with non-smoking pregnant or post-partum women exposed to second hand smoke. \- Identifying participants: Community gatekeepers and lady health workers will be used to identify expectant and new fathers, who are active smokers, along with pregnant and post-partum women who are exposed to SHS. \- Consenting participants A written and signed consent form will be obtained from all of the participants.

You may qualify if:

• Non smoking pregnant women exposed to second hand smoke
• Non smoking women in post partum period exposed to second hand smoke
• Expectant or new fathers who smoke
• Respondents residing in rural and per urban slums of Rawalpindi district
• Respondents who consent to participate in the study

You may not qualify if:

• Non smoking fathers
• Women not exposed to second hand smoke

Sponsors & Collaborators

• University of Edinburgh: lead
• Maternal, Neonatal and Child Health Research Network: collaborator

Study Sites (1)

MNCHRN

Islamabad, Federal, 44000, Pakistan

Location

Study Officials

• Dr Tabish Hazir, MBBS, FRCPCH

  Maternal, Neonatal and Child Health Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: July 27, 2020
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

PA (1)