A qualitative study of the factors influencing recruitment to a pilot trial on the prevention of striae gravidarum

Abstract

Background: Striae gravidarum are a common occurrence in pregnancy and many women use a topical product to prevent their development or lessen their appearance if they do develop. There is a lack of evidence on the effectiveness of many of the products used by women. This study arose from challenges in recruitment to a pilot randomised trial (ISRCTN trial registration number:76992326) designed to evaluate the feasibility of a definitive trial to compare a moisturising oil to no treatment in the prevention and reduction in severity of striae gravidarum. The study reported here explored the factors influencing recruitment to that pilot trial. Methods: A qualitative descriptive study was undertaken involving primigravid women attending an Irish maternity hospital. Data were collected by semi-structured telephone interviews over a four-week period and analysed using the framework method of analysis. Fifteen interview transcripts were included in the analysis. Results: Four main themes consisting of twelve categories were identified from the interview data. The themes focused on women's prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation. In relation to influences on trial participation, the possibility of being randomised to the non-intervention or control group was a deterrent for many women. Conclusions: The prevention of stretch marks is important to pregnant women, as is their choice of product to prevent them. Offering women the opportunity to be part of a trial that would be of low burden and would test a well-known product may optimise recruitment. However, reluctance to be randomised because of the possibility of being allocated to the non-intervention control group suggests that further work is needed in this field on how best to communicate uncertainty to potential participants.

Study on the methodology of striae gravidarum severity evaluation

“…The striae gravidarum presents as irregular purple or light red parallel and slightly concave expansion stripes in abdominal skin, and gradually fading into silver bright stripes [ 3 ]. Striae gravidarum brings both psychological burden and mental stress to pregnant women, leading a decrease of their life quality [ 4 ]. The occurrence and treatment have always been a worldwide concern in present medical research [ 5 , 6 ].…”

Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study

“…Previous trials on myo-inositol supplementation in pregnancy reported consent rates over 70% but had a predominantly Caucasian population 15 16. Other pregnancy trials reported similar attrition rates to the EMmY study,15 16 and made reference to phone-based reminders and diaries as crucial to adherence 17 18. The EMmY study was not powered to detect any statistical differences in clinical or laboratory outcomes, including for gestational diabetes.…”

Patients’ Perspectives of Grafting Materials in Implant Dentistry

“…Similar prompt questions were asked using an interview guide designed and agreed by all authors; additional questions were triggered by responses, and these were permitted as the interview’s policy. [ 17 ] The in-depth interviews also encouraged participants to communicate freely in their style and tempo. [ 18 ]…”