Project description:ObjectiveTo quantify differences in assessing preterm delivery when calculating gestational age from last menstrual period (LMP) versus ultrasonography biometry.MethodsThe Zambian Preterm Birth Prevention Study is an ongoing prospective cohort study that commenced enrolment in August 2015 at Women and Newborn Hospital of University Teaching Hospital in Lusaka, Zambia. Women at less than 20 weeks of pregnancy who were enrolled between August 17, 2015, and August 31, 2017, and underwent ultrasonography examination were included in the present analysis. The primary outcome was the difference between ultrasonography- and LMP-based estimated gestational age. Associations between baseline predictors and outcomes were assessed using simple regression. The proportion of preterm deliveries using LMP- and ultrasonography-derived gestational dating was calculated using Kaplan-Meier analysis.ResultsThe analysis included 942 women. The discrepancy between estimating gestational age using ultrasonography and LMP increased with greater gestational age at presentation and among patients with no history of preterm delivery. In a Kaplan-Meier analysis of 692 deliveries, 140 (20.2%, 95% confidence interval [CI] 17.7-23.0) and 79 (11.4%, 95% CI 9.6-13.6) deliveries were classified as preterm by LMP and ultrasonography estimates, respectively.ConclusionTaking ultrasonography as a standard, a bias was observed in LMP-based gestational age estimates, which increased with advancing gestation at presentation. This resulted in misclassification of term deliveries as preterm.
Project description:BackgroundGestational age estimation is key to the provision of abortion, to ensure safety and successful termination of pregnancy. We compared gestational age based on reported last menstrual period and ultrasonography among a large sample of women in Mexico City's public first trimester abortion program, Interrupcion Legal de Embarazo (ILE).MethodsWe conducted a retrospective study of 43,219 clinical records of women seeking abortion services in the public abortion program from 2007 to 2015. We extracted gestational age estimates in days based on last menstrual period and ultrasonography. We calculated the proportion of under- and over-estimation of gestational age based on last menstrual period versus ultrasonography. We compared overall differences in estimates and focused on discrepancies at two relevant cut-offs points (70 days for medication abortion eligibility and 90 days for ILE program eligibility).ResultsOn average, ultrasonography estimation was nearly 1 (- 0.97) days less than the last menstrual period estimation (SD = 13.9), indicating women tended to overestimate the duration of their pregnancy based on recall of date of last menstrual period. Overall, 51.4% of women overestimated and 38.5% underestimated their gestations based on last menstrual period. Using a 70-day limit, 93.8% of women who were eligible for medication abortion based on ultrasonography would have been correctly classified using last menstrual period estimation alone. Using the 90-day limit for ILE program eligibility, 96.0% would have been eligible for first trimester abortion based on last menstrual period estimation alone.ConclusionsThe majority of women can estimate gestational age using last menstrual period date. Where available, ultrasonography can be used, but it should not be a barrier to providing care.
Project description:BackgroundAccurate estimation of gestational age is important for both clinical and public health purposes. Estimates of gestational age using fetal ultrasound measurements are considered most accurate but are frequently unavailable in low- and middle-income countries. The objective of this study was to assess the validity of last menstrual period and Farr neonatal examination estimates of gestational age, compared to ultrasound estimates, in a large cohort of women in Vietnam.MethodsData for this analysis come from a randomized, placebo-controlled micronutrient supplementation trial in Vietnam. We analyzed 912 women with ultrasound and prospectively-collected last menstrual period estimates of gestational age and 685 women with ultrasound and Farr estimates of gestational age. We used the Wilcoxon signed rank sum test to assess differences in gestational age estimated by last menstrual period or Farr examination compared to ultrasound and computed the intraclass correlation coefficient (ICC) and concordance correlation coefficient (CCC) to quantify agreement between methods. We computed the Kappa coefficient (κ) to quantify agreement in preterm, term and post-term classification.ResultsThe median gestational age estimated by ultrasound was 273.9 days. Gestational age was slightly overestimated by last menstrual period (median 276.0 days, P < 0.001) and more greatly overestimated by Farr examination (median 286.7 days, P < 0.001). Gestational age estimates by last menstrual period and ultrasound were moderately correlated (ICC = 0.78) and concordant (CCC = 0.63), whereas gestational age estimates by Farr examination and ultrasound were weakly correlated (ICC = 0.26) and concordant (CCC = 0.05). Last menstrual period and ultrasound estimates of gestational age were within ± 14 days for 88.4% of women; Farr and ultrasound estimates were within ± 14 days for 55.8% of women. Last menstrual period and ultrasound estimates of gestational age had higher agreement in term classification (κ = 0.41) than Farr and ultrasound (κ = 0.05).ConclusionIn this study of women in Vietnam, we found last menstrual period provided a more accurate estimate of gestational age than the Farr examination when compared to ultrasound. These findings provide useful information about the utility and accuracy of different methods to estimate gestational age and suggest last menstrual period may be preferred over Farr examination in settings where ultrasound is unavailable.Trial registrationThe trial was registered at ClinicalTrials.Gov as NCT01665378 on August 13, 2012.
Project description:Introduction and objectiveValidation studies of algorithms for pregnancy outcomes based on International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes are important for conducting drug safety research using administrative claims databases. To facilitate the conduct of pregnancy safety studies, this exploratory study aimed to develop and validate ICD-10-CM-based claims algorithms for date of last menstrual period (LMP) and pregnancy outcomes using medical records.MethodsUsing a mother-infant-linked claims database, the study included women with a pregnancy between 2016-2017 and their infants. Claims-based algorithms for LMP date utilized codes for gestational age (Z3A codes). The primary outcomes were major congenital malformations (MCMs) and spontaneous abortion; additional secondary outcomes were also evaluated. Each pregnancy outcome was identified using a claims-based simple algorithm, defined as presence of ≥ 1 claim for the outcome. Positive predictive values (PPV) and 95% confidence intervals (CI) were calculated.ResultsOverall, 586 medical records were sought and 365 (62.3%) were adjudicated, including 125 records each for MCMs and spontaneous abortion. Last menstrual period date was validated among maternal charts procured for pregnancy outcomes and fewer charts were adjudicated for the secondary outcomes. The median difference in days between LMP date based on Z3A codes and adjudicated LMP date was 4.0 (interquartile range: 2.0-10.0). The PPV of the simple algorithm for spontaneous abortion was 84.7% (95% CI 78.3, 91.2). The PPV for the MCM algorithm was < 70%. The algorithms for the secondary outcomes pre-eclampsia, premature delivery, and low birthweight performed well, with PPVs > 70%.ConclusionsThe ICD-10-CM claims-based algorithm for spontaneous abortion performed well and may be used in pregnancy studies. Further algorithm refinement for MCMs is needed. The algorithms for LMP date and the secondary outcomes would benefit from additional validation in a larger sample.
Project description:ObjectivesWe examined gestational age (GA) estimates for live and still births, and prematurity rates based on last menstrual period (LMP) compared with ultrasonography (USG) among pregnant women at seven sites in six low-resource countries.DesignProspective cohort study SETTING AND PARTICIPANTS: This study included data from the Global Network's population-based Maternal and Newborn Health Registry which follows pregnant women in six low-income and middle-income countries (Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia). Participants in this analysis were 42 803 women, including their 43 230 babies, who registered for the study in their first trimester based on GA estimated either by LMP or USG and had a live or stillbirth with an estimated GA of 20-42 weeks.Outcome measuresGA was estimated in weeks and days based on LMP and/or USG. Prematurity was defined as GA of 20 weeks+0 days through 36 weeks+6 days, calculated by both USG and LMP.ResultsOverall, average GA varied ≤1 week between LMP and USG. Mean GA for live births by LMP was lower than by USG (adjusted mean difference (95% CI) = -0.23 (-0.29 to -0.17) weeks). Among stillbirths, a higher GA was estimated by LMP than USG (adjusted mean difference (95% CI)= 0.42 (0.11 to 0.72) weeks). Preterm birth rates for live births were significantly higher when dated by LMP (adjusted rate difference (95% CI)= 4.20 (3.56 to 4.85)). There was no significant difference in preterm birth rates for stillbirths.ConclusionThe small differences in GA for LMP versus USG in the Guatemalan and Indian sites suggest that LMP may be a useful alternative to USG for GA dating during the first trimester until availability of USG improves in those areas. Further research is needed to assess LMP for first-trimester GA dating in other regions with limited access to USG.Trial registration numberNCT01073475.
Project description:BackgroundThe best method of gestational age assessment is by ultrasound in the first trimester; however, this method is impractical in large field trials in rural areas. Our objective was to assess the validity of gestational age estimated from prospectively collected date of last menstrual period (LMP) using crown-rump length (CRL) measured in early pregnancy by ultrasound.MethodsAs part of a large, cluster-randomized, controlled trial in rural Bangladesh, we collected dates of LMP by recall and as marked on a calendar every 5 weeks in women likely to become pregnant. Among those with a urine-test confirmed pregnancy, a subset with gestational age of <15 weeks (n = 353) were enrolled for ultrasound follow-up to measure CRL. We compared interview-assessed LMP with CRL gestational age estimates and classification of preterm, term, and post-term births.ResultsLMP-based gestational age was higher than CRL by a mean (SD) of 2.8 (10.7) days; differences varied by maternal education and preterm birth (P < 0.05). Lin's concordance correlation coefficient was good at ultrasound [0.63 (95 % CI 0.56, 0.69)] and at birth [0.77 (95 % CI 0.73, 0.81)]. Validity of classifying preterm birth was high but post-term was lower, with specificity of 96 and 89 % and sensitivity of 86 and 67 %, respectively. Results were similar by parity.ConclusionsProspectively collected LMP provided a valid estimate of gestational age and preterm birth in a rural, low-income setting and may be a suitable alternative to ultrasound in programmatic settings and large field trials.Trial registrationClinicalTrials.gov NCT00860470.
Project description:BackgroundA reliable expected date of delivery (EDD) is important for pregnant women in planning for a safe delivery and critical for management of obstetric emergencies. We compared the accuracy of LMP recall, an early ultrasound (EUS) and a Smartphone App in predicting the EDD in South African pregnant women. We further evaluated the rates of preterm and post-term births based on using the different measures.MethodsThis is a retrospective sub-study of pregnant women enrolled in a randomized controlled trial between October 2017-December 2019. EDD and gestational age (GA) at delivery were calculated from EUS, LMP and Smartphone App. Data were analysed using SPSS version 25. A Bland-Altman plot was constructed to determine the limits of agreement between LMP and EUS.ResultsThree hundred twenty-five pregnant women who delivered at term (≥ 37 weeks by EUS) and without pregnancy complications were included in this analysis. Women had an EUS at a mean GA of 16 weeks and 3 days). The mean difference between LMP dating and EUS is 0.8 days with the limits of agreement 31.4-30.3 days (Concordance Correlation Co-efficient 0.835; 95%CI 0.802, 0.867). The mean(SD) of the marginal time distribution of the two methods differ significantly (p = 0.00187). EDDs were < 14 days of the actual date of delivery (ADD) for 287 (88.3%;95%CI 84.4-91.4), 279 (85.9%;95%CI 81.6-89.2) and 215 (66.2%;95%CI 60.9-71.1) women for EUS, Smartphone App and LMP respectively but overall agreement between EUS and LMP was only 46.5% using a five category scale for EDD-ADD with a kappa of .22. EUS 14-24 weeks and EUS < 14 weeks predicted EDDs < 14 days of ADD in 88.1% and 79.3% of women respectively. The proportion of births classified as preterm (< 37 weeks) was 9.9% (95%CI 7.1-13.6) by LMP and 0.3% (95%CI 0.1-1.7) by Smartphone App. The proportion of post-term (> 42 weeks gestation) births was 11.4% (95%CI 8.4-15.3), 1.9% (95%CI 0.9-3.9) and 3.4% (95%CI 1.9-5.9) by LMP, EUS and Smartphone respectively.ConclusionsEUS and Smartphone App were the most accurate to estimate the EDD in pregnant women. LMP-based dating resulted in misclassification of a significantly greater number of preterm and post-term deliveries compared to EUS and the Smartphone App.
Project description:Abortion is regulated in Mexico at the state level, and it is permitted under certain criteria in all 32 states, except in Mexico City where first-trimester abortion is decriminalized. Yet, more than a million abortions occur in Mexico each year. But most terminations occurring outside of Mexico City are clandestine and unsafe due to profound stigma against the procedure, lack of trained providers, lack of knowledge of where to find a safe abortion and poor knowledge of the laws. While this situation is moderated by the increasing use of misoprostol, a relatively safe method of abortion, the safety of the procedure cannot be assured in restrictive legal contexts. The purpose of this study is to explore women's experiences with induced abortion in three federal entities with different legal contexts, and whether abortion seeking behavior and experiences differ across these settings. The study was carried out in three states, representing three different degrees of restrictiveness of abortion legislation. Queretaro with the "most restrictive" law, Tabasco with a "moderately restrictive" law, and Mexico state with the "least restrictive" law. We hypothesize that women living in more restrictive states will resort to the use of more unsafe and risky methods and providers for their abortion than their counterparts in less restrictive states. Women who recently obtained abortions were selected through snowball sampling and qualitative data were collected from them using semi-structured indepth interviews. Data collection took place between mid-2014 and mid-2015, with a final sample size N = 60 (20 from each state). Various themes involved in the process of abortion seeking behavior were developed from the IDIs and examined here: women's knowledge of the abortion law in their state, reasons for having an abortion; the methods and providers used and women's positive and negative experiences with abortion methods and providers used. Our results indicate that abortion safety is not associated with the restrictiveness of abortion legislation. Findings show that there is a new pattern of abortion service provision in Mexico, with misoprostol, a relatively safe and easy to use method, playing an important role. Nevertheless, while access to misoprostol tends to increase the safety of abortion, the improvement is moderated by women and their informants (relatives, friends and partners) not having accurate information on how to safely self-induce an abortion with misoprostol. On the other hand, some women manage to have safe abortion in illegal setting by going to Mexico City or with the support of NGOs knowlegeable on abortion. Findings demonstrate the importance of decriminalization of abortion, but meanwhile, harm reduction strategies, including promotion of accurate information about self-use of misoprostol where abortion is legally restricted will result in safe abortion.
Project description:ObjectiveTo explore the prevalence and determinants of calendar literacy and last menstrual period (LMP) recall among women in Bangladesh.DesignCross-sectional survey.SettingsTwo rural subdistricts and one urban area from three Northern districts of Bangladesh.ParticipantsWe interviewed 2731 women who had a live birth in the last 1 year.Primary and secondary outcome measuresThe primary outcome variable was LMP recall and the secondary outcome was calendar literacy.ResultsThe majority of participants (65%) correctly mentioned the current date according to the English calendar while 12% mentioned according to the Bengali calendar. During the interview sessions, we used three different calendars: Bengali, English and Hijri to assess calendar literacy. We asked women to mark the current date using the calendar on the day of the interview. Almost 61% women marked the English calendar, 16% marked the Bengali calendar and 4% marked the Hijri calendar correctly. Sixty-three per cent women were found as calendar literate who marked any of the calendars. Among the participants, 58% had calendars available at their home and only 10% of women used calendars to track their LMPs. Overall, 53% women were able to recall their recent LMP. Among the calendar literate, 60% could recall their LMPs. Factors found associated with recalling LMP were: completed eight or more years of schooling (adj.OR 1.39), primigravida (adj.OR 1.88), the richest wealth quintile (adj.OR 1.55) and calendar literacy (adj.OR 1.59).ConclusionsDespite having reasonable calendar literacy and availability, the use of calendars for tracking LMP found very low. Calendar literacy and sociodemographic characteristics were found as the key factors associated with LMP recall. Maternal, neonatal and child health programmes in low-resource settings can promote a simple tool like calendar and target the communities where ultrasound is not available to ensure accurate LMP recall for early pregnancy registration and timely antenatal care coverage.
Project description:BackgroundGestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. Menstrual based dating, ultrasound based dating, and neonatal estimates are the primarily used methods for assessing GA; all of which have some strength and weaknesses that require critical consideration. Last menstrual period (LMP) is simple, low-cost self-reported information, recommended by the World Health Organization for estimating GA but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. The goal of this study is therefore to improve recall and reporting of LMP and by doing so increase the accuracy of LMP based GA assessment in a rural population of Bangladesh where antenatal care-seeking, availability and utilization of USG is low.MethodWe propose to conduct a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three interventions to improve recall of GA with a no intervention arm. The interventions include (i) counselling and a paper based calendar (ii) counselling and a cell phone based SMS alert system (iii) counselling and smart-phone application. The trial is being conducted among 3360 adolescent girls and recently married women in Mirzapur sub-district of Bangladesh.DiscussionEnrolment of study participants continued from January 24, 2017 to March 29, 2017. Data collection and intervention implementation is ongoing and will end by February, 2019. Data analysis will measure efficacy of interventions in improving the recall of LMP date among enrolled participants. Results will be reported following CONSORT guideline. The innovative conventional & e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where m-Health initiatives are proliferating with active support from all sectors in policy and implementation.Trial registrationClinicalTrials.gov NCT02944747 . The trial has been registered before starting enrolment on 24 October 2016.