Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India : study protocol and intervention adaptation of a randomised control trial

The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

Sex, a one mans show : Perceptions and experience of sexuality, contraceptives, unwanted pregnancy and unsafe abortion among young people in Kisumu, Kenya – A qualitative study

This study aimed to explore perceptions and experiences concerning sexuality, contraceptives, unwanted pregnancy and unsafe abortion among young people in Kisumu, Kenya. The design of the study was inductive with a qualitative approach using personal in-depth interviews. Eight participants (four female and four male) were asked to describe their perceptions and experience concerning sexuality, contraceptives, unwanted pregnancies and unsafe abortion. The result showed that culture and norms, misconceptions and gender based power in sexuality are factors that impact Sexual Reproductive Health among young people in Kisumu today. Unwanted pregnancy was described as a shame, a burden and a destroyed life which lead to many unsafely induced abortions. The findings indicate that youth interventions are important, such as engaging young men in unwanted pregnancy and thus unsafe abortions and to empower young women.

Lifestyle and health status in a sample of Swedish women four years after pregnancy : a comparison of women with a history of normal pregnancy and women with a history of gestational diabetes mellitus

Background: Despite the recommendations to continue the regime of healthy food and physical activity (PA) postpartum for women with previous gestational diabetes mellitus (GDM), the scientific evidence reveals that these recommendations may not be complied to. This study compared lifestyle and health status in women whose pregnancy was complicated by GDM with women who had a normal pregnancy and delivery. Methods: The inclusion criteria were women with GDM (ICD-10: O24.4 A and O24.4B) and women with uncomplicated pregnancy and delivery in 2005 (ICD-10: O80.0). A random sample of women fulfilling the criteria (n = 882) were identified from the Swedish Medical Birth Register. A questionnaire was sent by mail to eligible women approximately four years after the pregnancy. A total of 444 women (50.8%) agreed to participate, 111 diagnosed with GDM in their pregnancy and 333 with normal pregnancy/ delivery. Results: Women with previous GDM were significantly older, reported higher body weight and less PA before the index pregnancy. No major differences between the groups were noticed regarding lifestyle at the follow-up. Overall, few participants fulfilled the national recommendations of PA and diet. At the follow-up, 19 participants had developed diabetes, all with previous GDM. Women with previous GDM reported significantly poorer self-rated health (SRH), higher level of sick-leave and more often using medication on regular basis. However, a history of GDM or having overt diabetes mellitus showed no association with poorer SRH in the multivariate analysis. Irregular eating habits, no regular PA, overweight/obesity, and regular use of medication were associated with poorer SRH in all participants. Conclusions: Suboptimal levels of PA, and fruit and vegetable consumption were found in a sample of women with a history of GDM as well as for women with normal pregnancy approximately four years after index pregnancy. Women with previous GDM seem to increase their PA after childbirth, but still they perform their PA at lower intensity than women with a history of normal pregnancy. Having GDM at index pregnancy or being diagnosed with overt diabetes mellitus at follow-up did not demonstrate associations with poorer SRH four years after delivery.

Women's acceptability of misoprostol treatment for incomplete abortion by midwives and physicians : secondary outcome analysis from a randomized controlled equivalence trial at district level in Uganda

OBJECTIVE: This study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians. METHODS: This was an analysis of secondary outcomes from a multi-centre randomized controlled equivalence trial at district level in Uganda. Women with first trimester incomplete abortion were randomly allocated to clinical assessment and treatment with misoprostol by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and stratified for health care facility. Acceptability was measured in expectations and satisfaction at a follow up visit 14-28 days following treatment. Analysis of women's overall acceptability was done using a generalized linear mixed-effects model with an equivalence range of -4% to 4%. The study was not masked. The trial is registered at ClinicalTrials.org, NCT 01844024. RESULTS: From April 2013 to June 2014, 1108 women were assessed for eligibility of which 1010 were randomized (506 to midwife and 504 to physician). 953 women were successfully followed up and included in the acceptability analysis. 95% (904) of the participants found the treatment satisfactory and overall acceptability was found to be equivalent between the two study groups. Treatment failure, not feeling calm and safe following treatment, experiencing severe abdominal pain or heavy bleeding following treatment, were significantly associated with non-satisfaction. No serious adverse events were recorded. CONCLUSIONS: Treatment of incomplete abortion with misoprostol by midwives and physician was highly, and equally, acceptable to women. TRIAL REGISTRATION: ClinicalTrials.gov NCT01844024.

No consensus on gestational diabetes mellitus screening regimes in Sweden : pregnancy outcomes in relation to different screening regimes 2011 to 2012, a cross-sectional study

Background: Although associated adverse pregnancy outcomes, no international or Swedish consensus exists that identifies a cut-off value or what screening method to use for definition of gestational diabetes mellitus. This study investigates the following: i) guidelines for screening of GDM; ii) background and risk factors for GDM and selection to OGTT; and iii) pregnancy outcomes in relation to GDM, screening regimes and levels of OGTT 2 hour glucose values. Methods: This cross-sectional and population-based study uses data from the Swedish Maternal Health Care Register (MHCR) (2011 and 2012) combined with guidelines for GDM screening (2011-2012) from each Maternal Health Care Area (MHCA) in Sweden. The sample consisted of 184, 183 women: 88, 140 in 2011 and 96,043 in 2012. Chi-square and two independent samples t-tests were used. Univariate and multivariate logistic regression analyses were performed. Results: Four screening regimes of oral glucose tolerance test (OGTT) (75 g of glucose) were used: A) universal screening with a 2-hour cut-off value of 10.0 mmol/L; B) selective screening with a 2-hour cut-off value of 8.9 mmol/L; C) selective screening with a 2-hour cut-off value of 10.0 mmol/L; and D) selective screening with a 2-hour cut-off value of 12.2 mmol/L. The highest prevalence of GDM (2.9%) was found with a 2-hour cut-off value of 8.9 mmol/L when selective screening was applied. Unemployment and low educational level were associated with an increased risk of GDM. The OR was 4.14 (CI 95%: 3.81-4.50) for GDM in obese women compared to women with BMI <30 kg/m(2). Women with non-Nordic origin presented a more than doubled risk for GDM compared to women with Nordic origin (OR = 2.24; CI 95%: 2.06-2.43). Increasing OGTT values were associated with increasing risks of adverse pregnancy outcomes. Conclusions: There was no consensus regarding screening regimes for GDM from 2011 through 2012 when four different regimes were applied in Sweden. Increasing levels of OGTT 2-hour glucose values were strongly associated with adverse pregnancy outcomes. Based on these findings, we suggest that Sweden adopts the recent recommendations of the International Association of Diabetes and Pregnancy Study Group (IADPSG) concerning the performance of OGTT and the diagnostic criteria for GDM.

Pregnancy-related low back pain and pelvic girdle pain approximately 14 months after pregnancy : pain status, self-rated health and family situation

Background: Pelvic girdle pain (PGP) in pregnancy is distinct from pregnancy-related low back pain (PLBP). However, women with combined PLBP and PGP report more serious consequences in terms of health and function. PGP has been estimated to affect about half of pregnant women, where 25% experience serious pain and 8% experience severe disability. To date there are relatively few studies regarding persistent PLBP/PGP postpartum of more than 3 months, thus the main objective was to identify the prevalence of persistent PLBP and PGP as well as the differences over time in regard to pain status, self-rated health (SRH) and family situation at 12 months postpartum. Methods: The study is a 12 month follow-up of a cohort of pregnant women developing PLBP and PGP during pregnancy, and who experienced persistent pain at 6 month follow-up after pregnancy. Women reporting PLBP/PGP (n = 639) during pregnancy were followed up with a second questionnaire at approximately six month after delivery. Women reporting recurrent or persistent LBP/PGP at the second questionnaire (n = 200) were sent a third questionnaire at 12 month postpartum. Results: A total of 176 women responded to the questionnaire. Thirty-four women (19.3%) reported remission of LBP/PGP, whereas 65.3% (n = 115) and 15.3% (n = 27), reported recurrent LBP/PGP or continuous LBP/PGP, respectively. The time between base line and the 12 months follow-up was in actuality 14 months. Women with previous LBP before pregnancy had an increased odds ratio (OR) of reporting 'recurrent pain' (OR = 2.47) or 'continuous pain' (OR = 3.35) postpartum compared to women who reported 'no pain' at the follow-up. Women with 'continuous pain' reported statistically significant higher level of pain at all measure points (0, 6 and 12 months postpartum). Non-responders were found to report a statistically significant less positive scoring regarding relationship satisfaction compared to responders. Conclusions: The results from this study demonstrate that persistent PLBP/PGP is a major individual and public health issue among women 14 months postpartum, negatively affecting their self-reported health. However, the perceived relationship satisfaction seems to be stable between the groups.

Struggling with daily life and enduring pain : a qualitative study of women's experiences with pelvic girdle pain during pregnancy

Background. Few studies have investigated the experiences of living with pelvic girdle pain (PGP) and its impact on pregnant women’s lives. To address this gap in knowledge, this study investigates the experiences of women living with PGP during pregnancy. Methods. A purposive sample, of nine pregnant women with diagnosed PGP, were interviewed about their experiences. Interviews were recorded, transcribed to text and analysed using a Grounded Theory approach. Results. The core category that evolved from the analysis of experiences of living with PGP in pregnancy was “struggling with daily life and enduring pain”. Three properties addressing the actions caused by PGP were identified: i) grasping the incomprehensible; ii) balancing support and dependence and iii) managing the losses. These experiences expressed by the informants constitute a basis for the consequences of PGP: iv) enduring pain; v) being a burden; vi) calculating the risks and the experiences of the informants as vii) abdicating as a mother. Finally, the informants’ experiences of the consequences regarding the current pregnancy and any potential future pregnancies is presented in viii) paying the price and reconsidering the future. A conceptual model of the actions and consequences experienced by the pregnant informants living with PGP is presented. Conclusions. PGP during pregnancy greatly affects the informant’s experiences of her pregnancy, her roles in relationships, and her social context. For informants with young children, PGP negatively affects the role of being a mother, a situation that further strains the experience. As the constant pain disturbs most aspects of the lives of the informants, improvements in the treatment of PGP is of importance as to increase the quality of life. This pregnancy-related condition is prevalent and must be considered a major public health concern during pregnancy.

Women's experiences of two different self-assessment methods for monitoring fetal movements in full-term pregnancy : a crossover trial

Background: Low maternal awareness of fetal movements is associated with negative birth outcomes. Knowledge regarding pregnant women's compliance with programs of systematic self-assessment of fetal movements is needed. The aim of this study was to investigate women's experiences using two different self-assessment methods for monitoring fetal movements and to determine if the women had a preference for one or the other method. Methods: Data were collected by a crossover trial; 40 healthy women with an uncomplicated full-term pregnancy counted the fetal movements according to a Count-to-ten method and assessed the character of the movements according to the Mindfetalness method. Each self-assessment was observed by a midwife and followed by a questionnaire. A total of 80 self-assessments was performed; 40 with each method. Results: Of the 40 women, only one did not find at least one method suitable. Twenty of the total of 39 reported a preference, 15 for the Mindfetalness method and five for the Count-to-ten method. All 39 said they felt calm, relaxed, mentally present and focused during the observations. Furthermore, the women described the observation of the movements as safe and reassuring and a moment for communication with their unborn baby. Conclusions: In the 80 assessments all but one of the women found one or both methods suitable for self-assessment of fetal movements and they felt comfortable during the assessments. More women preferred the Mindfetalness method compared to the count-to-ten method, than vice versa.