Pregnancy Clinical Trial
Official title:
Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin
Verified date | November 2023 |
Source | Tampere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.
Status | Active, not recruiting |
Enrollment | 1320 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent - Age >= 15 years - Ultrasound confirmed pregnancy - Quickening - Foetal age 14-26 gestation weeks - Maternal availability for follow-up during the entire study period Exclusion Criteria: - Known maternal tuberculosis, diabetes, kidney disease or liver disease - Any severe acute illness warranting hospital referral at enrollment visit - Mental disorder that may affect comprehension of the study or success of follow-up - Twin pregnancy - Pregnancy complications evident at enrollment visit (moderate to severe oedema, blood hemoglobin [Hb] concentration < 50 g/l, systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg) - Prior receipt of azithromycin during this pregnancy - Receipt of sulfadoxine and pyrimethamine within 28 days of enrollment - Known allergy to drugs containing sulfonamides, macrolides or pyrimethamine - History of anaphylaxis - History of any serious allergic reaction to any substance, requiring emergency medical care - Concurrent participation in any other clinical trial |
Country | Name | City | State |
---|---|---|---|
Malawi | College of Medicine, University of Malawi | Mangochi | Mangochi District |
Lead Sponsor | Collaborator |
---|---|
Tampere University | Academy of Finland, Foundation for Paediatric Research, Finland |
Malawi,
Aitken EH, Mbewe B, Luntamo M, Kulmala T, Beeson JG, Ashorn P, Rogerson SJ. Antibody to P. falciparum in pregnancy varies with intermittent preventive treatment regime and bed net use. PLoS One. 2012;7(1):e29874. doi: 10.1371/journal.pone.0029874. Epub 20 — View Citation
Aitken EH, Mbewe B, Luntamo M, Maleta K, Kulmala T, Friso MJ, Fowkes FJ, Beeson JG, Ashorn P, Rogerson SJ. Antibodies to chondroitin sulfate A-binding infected erythrocytes: dynamics and protection during pregnancy in women receiving intermittent preventi — View Citation
Hallamaa L, Cheung YB, Maleta K, Luntamo M, Ashorn U, Gladstone M, Kulmala T, Mangani C, Ashorn P. Child Health Outcomes After Presumptive Infection Treatment in Pregnant Women: A Randomized Trial. Pediatrics. 2018 Mar;141(3):e20172459. doi: 10.1542/peds.2017-2459. — View Citation
Kayentao K, Garner P, van Eijk AM, Naidoo I, Roper C, Mulokozi A, MacArthur JR, Luntamo M, Ashorn P, Doumbo OK, ter Kuile FO. Intermittent preventive therapy for malaria during pregnancy using 2 vs 3 or more doses of sulfadoxine-pyrimethamine and risk of low birth weight in Africa: systematic review and meta-analysis. JAMA. 2013 Feb 13;309(6):594-604. doi: 10.1001/jama.2012.216231. — View Citation
Lin JT, Mbewe B, Taylor SM, Luntamo M, Meshnick SR, Ashorn P. Increased prevalence of dhfr and dhps mutants at delivery in Malawian pregnant women receiving intermittent preventive treatment for malaria. Trop Med Int Health. 2013 Feb;18(2):175-8. doi: 10. — View Citation
Luntamo M, Kulmala T, Cheung YB, Maleta K, Ashorn P. The effect of antenatal monthly sulphadoxine-pyrimethamine, alone or with azithromycin, on foetal and neonatal growth faltering in Malawi: a randomised controlled trial. Trop Med Int Health. 2013 Apr;18 — View Citation
Luntamo M, Kulmala T, Mbewe B, Cheung YB, Maleta K, Ashorn P. Effect of repeated treatment of pregnant women with sulfadoxine-pyrimethamine and azithromycin on preterm delivery in Malawi: a randomized controlled trial. Am J Trop Med Hyg. 2010 Dec;83(6):12 — View Citation
Rantala AM, Taylor SM, Trottman PA, Luntamo M, Mbewe B, Maleta K, Kulmala T, Ashorn P, Meshnick SR. Comparison of real-time PCR and microscopy for malaria parasite detection in Malawian pregnant women. Malar J. 2010 Oct 6;9:269. doi: 10.1186/1475-2875-9-2 — View Citation
Xu J, Luntamo M, Kulmala T, Ashorn P, Cheung YB. A longitudinal study of weight gain in pregnancy in Malawi: unconditional and conditional standards. Am J Clin Nutr. 2014 Feb;99(2):296-301. doi: 10.3945/ajcn.113.074120. Epub 2013 Nov 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of preterm births | Proportion of babies who are born before 37 completed gestation weeks | once, after delivery | |
Primary | Number of serious adverse events | Death, life-threatening event, hospitalization, congenital anomaly, or any othe condition consedered an SAE by a study physician | Cumulative during pregnancy and neonatal period | |
Secondary | Percentage of low birth weight babies | Birth weight < 2500 g | Once, after delivery | |
Secondary | Mean birth weight | Measured in grams | Once, after delivery | |
Secondary | Mean duration of gestation | Measured in gestation weeks, expressed to one deciman, | Once, after delivery | |
Secondary | Percentage of low head circumference at birth | Below 2 standard deviations of the mean of international reference population | Once, after delivery | |
Secondary | Incidence of moderate underweight during infancy or childhood | weight for age Z-score < -2 | Cumulative during infancy and childhood | |
Secondary | Perinatal mortality | Stillbirths after 22 gestation weeks or within first 7 days of life / 1000 live births | Cumulative until 7 days of post-natal life | |
Secondary | Neonatal mortality | Deaths within first 28 days of life / 1000 live births | Cumulative until 28 days of post-natal life | |
Secondary | Infant mortality | Deaths within first 265 days of life / 1000 live births | Cumulative until 365 days of post-natal life | |
Secondary | Mean maternal blood haemoglobin concentration at each antenatal visit and at 1, 3, and 6 months after delivery | Measured with hemocue meter, expressed as grams / liter | Several antenatal and postnatal visits | |
Secondary | Percentage of women with mild, moderate or severe anaemia at every antenatal visit and at 1, 3, and 6 months after delivery | Cut-offs for mild, moderate and severa anaemia 110 g / l - 80 g / l - 50 g / l | Several antenatal and postnatal visits | |
Secondary | Percentage of women with peripheral blood malaria parasitaemia at 32 gestational weeks and at delivery | Measured with microscopy from fresh blood slides and with real-time PCR from dried blood spots | At enrolment, every 4 weeks thereafter and at delivery | |
Secondary | Maternal weight gain during pregnancy | grams / gestation week | Cumulative during pregnancy | |
Secondary | Mean number of maternal illness days during pregnancy | Self reported illness symptoms | Cumulative during pregnancy | |
Secondary | Prevalence of maternal chlamydia trachomatis, neisseria gonorrhoea, and vaginal trichomoniasis infection at 4 weeks after delivery | Chlamydia and gonorhoea measured from urine samples with a PCR, vaginal trichomoniasis measures with a wet microscopy | At 4 weeks after delivery | |
Secondary | Attained lenght / height | Measured as length until 2 years of age, then height; expressed in cm (one decimal) and as length / heigh for age Z-score | 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 60 months and 10-12 years of age | |
Secondary | Attained weight | Expressed in kg with two decimals and as weight for age Z-score | 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 60 months and 10-12 years of age | |
Secondary | Nutritional status | Mid-upper arm circumference, in mm (no decimals) | 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 60 months and 10-12 years of age | |
Secondary | Attained head circumference | Head circumference, in mm, no decimals | 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 60 months and 10-12 years of age | |
Secondary | Childhood mortality, % of subjects who have died by the 10-12 year follow-up visit | Deaths, information obtained from parents or other adults who have lived in the same household with the child | Cumulative incidence by 10-12 years of age | |
Secondary | Motor development, Griffiths test, sub-score | Summary score from questions in the gross motor and fine motor domain questions | 5 years of age | |
Secondary | Social development, Griffiths test, sub-score | Summary score from questions in the social development domain questions | 5 years of age | |
Secondary | Cognitive development, Raven's colour matrix, score | Summary score from 36 questions in the Raven's colour matrix test | 10-12 years of age | |
Secondary | Reaction time, milliseconds | This will be tested with an eye-tracking device (Tobii). Participants are asked to look from the fixation point to different directions or fixate the gaze at one point. We will measure the horizontal eye-movements (saccades) and calculate the reaction times, scoring the task correct/incorrect (direction).
This eye-tracking system is based on a Pupil Centre Corneal Reflection (PCCR) technique, in which near infrared illumination is reflected on the cornea relative to the center of the pupil. The eye-tracking cameras capture the light reflections and create a 3D model of the eye and head-position to track the participant's point of gaze at high temporal and spatial accuracy (60 Hz/0.4°). The results will be stored automatically into a data base. |
10-12 years of age | |
Secondary | Systolic blood pressure, mmHg | Will use oscillometric Mobil o Graph blood pressure monitoring system (accuracy +/- 3 mmHg), when the child is first sitting, then standing and last lying down. | 10-12 years of age | |
Secondary | Diastolic blood pressure, mmHg | Will use oscillometric Mobil o Graph blood pressure monitoring system (accuracy +/- 3 mmHg), when the child is first sitting, then standing and last lying down. | 10-12 years of age | |
Secondary | Central blood pressure, mmHg | Will use oscillometric Mobil o Graph blood pressure monitoring system (accuracy +/- 3 mmHg), when the child is first sitting, then standing and last lying down. | 10-12 years of age | |
Secondary | Pulse rate, beats / minutes | Will use oscillometric Mobil o Graph blood pressure monitoring system. We will measure pulse rate / minutes, when the child is first sitting, then standing and last lying down. | 10-12 years of age | |
Secondary | Vascular resistance, mmHg·min/l | Will use oscillometric Mobil o Graph blood pressure monitoring system. We will measure vascular resistance, when the child is first sitting, then standing and last lying down. | 10-12 years of age | |
Secondary | Lean body mass, expressed in kg, with one decimal | Body composition measured with 8-polar biompedance method (Seca® mBCA 515 Medical Body Composition Analyser), validated with Deuterium Dilution Technique with Analysis of Saliva Samples by Fourier Transform Infrared Spectrometry (FTIR) | 10-12 years of age | |
Secondary | Fat mass, expressed in kg, with one decimal | Body composition measured with 8-polar biompedance method (Seca® mBCA 515 Medical Body Composition Analyser), validated with Deuterium Dilution Technique with Analysis of Saliva Samples by Fourier Transform Infrared Spectrometry (FTIR) | 10-12 years of age | |
Secondary | Fat percentage, expressed proportion of body weight (per cent, with one decimal) | Body composition measured with 8-polar biompedance method (Seca® mBCA 515 Medical Body Composition Analyser), validated with Deuterium Dilution Technique with Analysis of Saliva Samples by Fourier Transform Infrared Spectrometry (FTIR) | 10-12 years of age | |
Secondary | Self-rated well-being, score | Self-reported well-being will be measured with 11 question panel with rating from 1-5 expressed as smileys. The questions consider about "how happy you are about the things you own, school, house you live, food, clothes, other pupils, friends, the family, safety feeling, the way you look, with yourself". Score for self-reported well-being will be calculated as a sum of ratings for each item divided by the number of items with non-missing data. There are two items related to the child's school and they are not applicable if the child does not go to school. The minimum score for self-reported well-being is 1 and the maximum is 5, and the score will be expressed with one decimal. | 10-12 years of age |
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