Each participant started by preoxygenation of 100% oxygen for 3 minutes. Then, parturients breath 1% of sevoflurane in mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min. Values of inspired (FI) and end-tidal (FET) concentrations of sevoflurane, oxygen and respiratory rate (RR) measured by end-tidal carbon dioxide (EtC02) were monitored continuously and recorded at 30 seconds intervals by a gas analyzer.
30 seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure. HR, FI and FET concentration of sevoflurane, Sp02 and EtC02 will be recorded at 30-s interval during ECV. Non-invasive BP will be recorded every one minute. Duration of ECV in addition to level of difficulty estimated by obstetrician will be recorded.
ECV considered successful when a cephalic presentation, confirmed by ultrasound scan, achieved.

If the parturient is assigned to the control (nonintervention) group, the participants will not receive any medications neither tocolytics nor analgesics as the routine care in our hospital. However, the participants will be monitored throughout the procedure for vital signs and for pain scores as in the intervention group.

Version of Uterus

Each participant started by preoxygenation of 100% oxygen for 3minutes. Then, parturients breath 1% of sevoflurane in a mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min.
Thirty seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure.The duration of ECV in addition to the level of difficulty estimated by obstetricians will be recorded. Usually, the duration of ECV does not exceed 10 minutes.
The intervention will be stopped if the woman reported severe pain, if version could not be achieved readily, or if prolonged fetal bradycardia, uterine bleeding or placental abruption occurred.
Parturient will be kept in Post Anesthesia Care Unit (PACU) for 45minutes. CTG will be monitored during PACU stay.

Sevoflurane

Sevoflurane and Success of External Cephalic Version (ECV)

Effect of Sevoflurane on the Success of External Cephalic Version for Breech Presentation

ECV considered successful when a cephalic presentation assessed by direct palpation of maternal abdominal wall by obstetrician and confirmed by ultrasound scan is achieved.

The visual analogous scale used for this study measures from 0-10 the intensity of the pain. Where, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

The women's level of satisfaction with the procedure will be assessed using numerical rating scale (0 = completely dissatisfied, 10 = completely satisfied)

These complications include such as placental abruption, cord prolapse, abnormal cardiotocography, fetomaternal transfers and stillbirth

Possible adverse effects such as nausea, vomiting, drowsiness, hypotension and aspiration pneumonia.

mode of delivery might be either normal vaginal delivery or by cesarean section

Adel Alqarni

Assistant professor and consultant of anesthesia

King Saud University

ELGANs recruited to the study group in addition to standard of care will have continuous cerebral NIRS monitoring for the initial 72 hours and TNE studies at definitive time frames and a hemodynamic report will be provided to the clinical team using the results of the multimodal monitoring and clinical data. The report will be a description of the hemodynamic status without any suggestions for management.

ELGANs recruited into Standard arm will have the standard monitoring including cardiorespiratory monitoring. The invasive blood pressure monitoring, NIRS and TNE monitoring as per the clinical team's discretion - consistent with the current standard of care. No hemodynamic report will be provided routinely.

Hemodynamic Instability

The multimodal data comprising the clinical, biochemical, NIRS data and TNE where available will be used by the study team in such cases to reach a description of the hemodynamic status of the study infant and will be provided to the Clinical team.

Hemodynamic report

Royal Alexandra Hospital-NICU

Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit

Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit- Non-Blinded Randomized Control Trial

Higher the scores, higher the cardiovascular support

for the purpose of Validation of Vasoactive-Ventilation-Renal scores in the transition neonatal period

Kumar Kumaran

Clinical Assistant Professor, University of Alberta,

University of Alberta

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.

Pregnant women affected by HT, ID and IDA are enrolled and treated until delivery with oral administration of one capsule of 100 mg of bLf (Lattoglobina, Grunenthal, Italy) twice a day before meals. In twin pregnancies or in severe anemia, HT pregnant women are treated until delivery with two capsules of 100 mg of bLf twice a day, before meals.

Pregnant women affected by HT, ID and IDA are enrolled and treated until delivery with oral administration of 520 mg of ferrous sulfate (Ferro-Grad, Abbott Laboratories, USA), once a day during meal.

Pregnancy

Iron Deficiency

Iron Deficiency Anemia

One capsule of Lattoglobina contains 100 mg of bLf. Dosage: one capsule twice a day before meals. In twin pregnancy or in severe anemia the dosage is increased to 2 capsules twice a day before meals

Lattoglobina (Grunenthal) containing bLf

Dosage: one tablet/day containing 540 mg of ferrous sulfate during meals

FerroGrad by Abbott

Clinica Fabia Mater

Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies

Phase IV Study of Oral Administration of Bovine Lactoferrin (bLf) to Prevent and Cure Iron Deficiency (ID) and Iron Deficiency Anemia (IDA) Until Delivery in Hereditary Thrombophilia (HT) Affected Pregnant Women

Efficacy of bLf versus ferrous sulfate in preventing and curing iron deficiency and iron deficiency anemia

Control of side effects of oral administration of bLf and ferrous sulfate as:
gastrointestinal discomfort
nausea
vomiting
diarrhea
constipation

abruptio placentae/hypoxia

Sevoflurane and Success of External Cephalic Version (ECV)

Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit

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

Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies

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