Women in the intervention arm will be provided with the "Health Gauge" device. With this device, the women will be able to do self-monitoring of blood pressure as well as a few other things like heart rate, daily activities. Investigators will train our study participants (high-risk pregnant women) on how to use Salu Health Gauge to measure BP as well as how to charge them. Trained FFWs will visit the households weekly and synchronize the device with a tablet computer to collect the stored data. The FFWs will measure the weight of the participants using a digital weighing scale at enrollment and on a monthly bases thereafter. Investigators will keep monitoring up to termination of pregnancy. in any health issue arises, our health worker will ensure that an appropriate referral is made to a tertiary care facility. This intervention will be in addition to the conventional antenatal and postnatal care.

All those women randomized to the control arm will receive conventional antenatal and postnatal care only. Investigators will collect the outcome data from the households and/or the health centers by follow-up visits or over phone. Investigators will consell participants, women both in the control group, to make at least four antenatal visits. In addition, Investigators will provide counselling about eating healty and keeping physically active during pregnancy. Investigators will provide general nutrition education on taking balanced energy and protein diet.

Hypertension, Pregnancy-Induced

Hypertension, Essential Hypertension

Hypertension; Pre-Eclampsia

Hypertension in Pregnancy

Our study aimed to prevent hypertensive disorders of pregnancy. So only female can be enrolled in the study as participant due to their ability to be pregnant

Women in the intervention arm will be provided with the "Health Gauge" device. With this device, the women will be able to do self-monitoring of blood pressure as well as a few other things like heart rate, daily activities. We will also measure weight gain of the mothers at monthly basis.

Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain

Icddr,B

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure: A Pilot Randomized Controlled Trial

Recruitment rate is defined as number of participants recruited per month on average. This outcome is important because unforeseen enrolment challenges are crucial to identify in a pilot RCT.

Retention rate is defined as the proportion of participants who will fully participate in the study until follow-up period (from 20 week up to the delivery) ends.

Adherence is defined as the proportion of participants following the intervention protocol. There may be a number of reasons why the participant do not follow the intervention protocol properly. FFWs will enquire the reasons during weekly visits and note the causes and the number of times they have violated the protocol in a log sheet. Understandable protocol deviations (e.g., participant died) will be distinguished from protocol violations (e.g., participant removed the wearable gauge).

Participant acceptability of the device as intervention will be assessed two times during the follow-up period using a Likert scale with 5 level of qualitative response as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcomes. They will be assessed once during the third trimester and in the end of the study. The qualitative part will be reported narratively. up period using a Likert scale as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcome. They will be assessed once during the second trimester, once during the third trimester and finally once during the postnatal period. The qualitative part will be reported narratively.

Participant acceptability of the BP measurement procure as a part of the intervention will be assessed two times during the follow-up period using a Likert scale with 5 level of qualitative response as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcomes. They will be assessed once during the third trimester and in the end of the study. The qualitative part will be reported narratively.

The investigators will measure the gestational weight gain by using increase of maternal weight per month and increase of maternal weight per week. Weight will be measured in kilograms.

The investigators will record birth weight in every viable births and will record in grams (gm). Then investigators will compare the birth weight between two groups.

The investigators will measure the adverse consequences of pregnancy due to hypertension during pregnancy. The investigators will record all the episodes or occurrence of adverse events. This will compared in descriptive nature and compare between groups. Adverse events will be for mothers are: abruptio placenta, Disseminated coagulopathy, Pulmonary oedema/aspiration, acute renal failure, eclampsia, liver failure or hemorrhage, stroke, death. Fetal events like intrauterine death/stillbirth, preterm birth, small-for-gestational age, low birth weight, Hypoxia-neurologic injury, neonatal death, complications associated with LBW or preterm births

The investigators will motivate mothers to measure blood pressure in mm/Hg for at least six times in a day. Then investigators will prepare a complete profile of blood pressure for her pregnancy from 20 weeks of gestation up to the termination of pregnancy for each participants in intervention groups. The investigators will also make a profile of blood pressure among control groups with their recorded data measured by their respective health professionals (doctors and health workers). The investigators will take the average and compare the blood pressure in different time periods.

The investigators will motivate the mothers to measure the heart rate for 6 times a day with the health Gauge device. Then heart rate will be calculated in beats per minutes.

The investigators will measure the daily activity of pregnant mothers who are at risk of hypertension by step counts per day during their observation period.

The investigators will take data related to sleeping status of mothers and will be recorded as number of hours passed in different stages of sleeps. The investigators will make a profile for those mothers have higher risk for pregnancy related hypertension

The investigators will take the data of those mothers enrolled in the study related to their sociodemographic status.

International Centre for Diarrhoeal Disease Research, Bangladesh

Bill and Melinda Gates Foundation

Salu Design Group

This study is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (high-risk pregnant women) will be individually randomized 1:1 to the intervention arm who will regularly monitor their nutritional status (rate of gestational weight gain) using a digital weighing scale and continuously self-monitor their blood pressure using a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of to pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only.

Neither the participants nor the investigators or the assessors of outcomes can be blinded to allocation because of the obvious nature and the delivery procedure of the interventions which investigators are going to provide and thus, investigators are obliged to make the RCT non-blinded/open. However, it is prudent to mention that the outcomes of the trial are of objective nature. Furthermore, the randomization, as well as statistical analysis, will be carried out by someone unconnected to the recruitment process.

Transdermal Nicotine Patch + Progesterone (200 mgs BID)

Transdermal Nicotine Patch + Placebo (for Progesterone)

Transdermal Nicotine Patch + Progesterone (200 mgs BID)
Progesterone (200 mgs BID): TNP + Progesterone

TNP + Progesterone

Transdermal Nicotine Patch + Placebo (for Progesterone)
Placebo: TNP + Placebo

TNP + Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Cigarettes per day

Participants were asked on a scale from 1 (not motivated at all) to 10 (extremely motivated), how motivated are you to quit smoking?

Motivation to quit smoking

Lives with smoker

The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.

7-day Point Prevalence of Smoking Abstinence

Carbon Monoxide <10 Ppm

The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.

Change in Stroop Measure of Inhibitory Function

Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3".
Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2.

Change in Go/No Go Task Measure of Inhibitory Function

The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.

Transdermal Nicotine Patch + Progesterone (200 mgs BID)
Progesterone (200 mgs BID): Transdermal Nicotine Patch (TNP) + Progesterone

Change in Digit Symbol Task Measure of Inhibitory Function

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Positive and Negative Affect Schedule (PANAS) Total Score

Abstinence from 2 weeks post quit date to the one month follow up

Prolonged Abstinence Post Trial

Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up)

hyperplasia/seizures

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

Progesterone Augmentation of Nicotine Replacement Therapy Study

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