zithromax and Birth-Weight

Exposure during pregnancy to malaria and sexually-transmitted infections is associated with adverse birth outcomes including low birth weight (LBW). This study aimed at assessing if the adjunction of two doses of azithromycin to sulfadoxine-pyrimethamine for the intermittent preventive treatment of malaria in pregnancy can reduce LBW.. A two parallel-groups, open-label randomized controlled trial involving pregnant women (16 to 35 years of age and 12 to 24 weeks of gestation as confirmed by last menstrual period or fundal height) was conducted in rural Burkina Faso. Women were assigned in a 1:1 ratio either to use azithromycin (1 g daily for 2 days) during the second and third trimesters of pregnancy plus monthly sulfadoxine-pyrimethamine (1500/75 mg) (SPAZ) (intervention) or to continue using a monthly sulfadoxine-pyrimethamine (1500/75 mg) (SP) (control). Primary outcome was a LBW (birth weight measured within 24 h after birth < 2500 g). Secondary outcomes including stillbirth, preterm birth or miscarriage are reported together with safety data.. A total of 992 pregnant women underwent randomization (496 per group) and 898 (90.5%) valid birth weights were available (450 in SPAZ and 448 in SP). LBW incidence was 8.7% (39/450) in SPAZ and 9.4% (42/448) in controls (p-value = 0.79). Compared with controls, pregnant women with SPAZ showed a risk ratio (RR) of 1.16 (95% confidence interval (CI 0.64-2.08]) for preterm births, 0.75 (95% CI 0.17-3.35) for miscarriage and 0.64 (95% CI 0.25-1.64) for stillbirths. No treatment-related serious adverse events (SAEs) have been observed, and there was no significant difference in the number of SAEs (13.5% [67/496] in SPAZ, 16.7% [83/496] in SP, p-value = 0.18) or AEs (17.1% [85/496] in SPAZ, 18.8% [93/496] in SP, p-value = 0.56).. Adequate prevention regimen with monthly sulfadoxine-pyrimethamine given to all pregnant women has been proved to reduce the risk of LBW in malaria endemic areas. Adding azithromycin to the regimen does not offer further benefits, as far as women receive a malaria prevention regimen early enough during pregnancy. Trial registration Pan African Clinical Trial Registry ( https://pactr.samrc.ac.za/Search.aspx ): PACTR201808177464681. Registered 21 August 2018.

Topics: Abortion, Spontaneous; Antimalarials; Azithromycin; Birth Weight; Burkina Faso; Drug Combinations; Female; Humans; Infant; Infant, Low Birth Weight; Infant, Newborn; Malaria; Pregnancy; Premature Birth; Pyrimethamine; Stillbirth; Sulfadoxine

Intermittent preventive treatment in pregnancy (IPTp) with azithromycin and monthly sulfadoxine-pyrimethamine increased the mean child weight, mid-upper arm and head circumference at four weeks of age in a rural low-income setting. Now we assess for how long these gains were sustained during 0-5 years of age.. We enrolled 1320 pregnant Malawian women in a randomized trial and treated them with two doses of sulfadoxine-pyrimethamine (control) or monthly sulfadoxine-pyrimethamine as IPTp against malaria, or monthly sulfadoxine-pyrimethamine and two doses of azithromycin (AZI-SP) as IPTp against malaria and reproductive tract infections. Child weight, mid-upper arm circumference, head circumference and weight-for-height Z-score were recorded at one, six, 12, 24, 36, 48, and 60 months.. Throughout follow-up, the mean child weight was approximately 100 g higher (difference in means 0.12 kg, 95% CI 0.04-0.20, P = 0.003 at one month; 0.19 kg, 95% CI 0.05-0.33, P = 0.007, at six months), mean head circumference 2 mm larger (0.3 cm, 95% CI 0.1 to 0.5, P = 0.004 at one month) and the cumulative incidence of underweight by five years of age was lower (hazard ratio 0.74, 95% CI 0.60 to 0.90, P = 0.002) in the AZI-SP group than in the control group. The 2 mm difference in the mean mid-upper arm circumference at one month (0.2 cm, 95% CI 0.0 to 0.3, P = 0.007) disappeared after three years of age. There was no difference in mean weight-for-height Z-score at any time point.. In Malawi, IPTp with azithromycin and monthly sulfadoxine-pyrimethamine has a modest, 3-5-year positive impact on child weight, mid-upper arm circumference and head circumference, but not on weight-for-height Z-score.

Topics: Adult; Anti-Bacterial Agents; Antimalarials; Arm; Azithromycin; Birth Weight; Child; Child, Preschool; Drug Combinations; Female; Follow-Up Studies; Head; Humans; Incidence; Infant; Infant, Newborn; Malaria; Malawi; Male; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Complications, Parasitic; Pyrimethamine; Respiratory Tract Infections; Sulfadoxine

To examine the potential to reduce foetal and neonatal growth faltering through intermittent preventive treatment in pregnancy (IPTp) of malaria and reproductive tract infections with monthly sulphadoxine-pyrimethamine (SP), alone or with two doses of azithromycin.. We enrolled 1320 women with uncomplicated second trimester pregnancies into a randomised, partially placebo controlled, outcome assessor-blinded clinical trial in Malawi. The participants received either two doses of SP (control), SP monthly (monthly SP) or SP monthly and azithromycin (1 g) twice (AZI-SP). Newborn size was measured within two days of birth and infant growth at four weeks of age.. Babies in the AZI-SP group were on average (95% CI) 140 g (70-200) heavier at birth and 0.6 cm (0.2-0.9) longer at four weeks of age than control group babies. Corresponding differences between the monthly SP and control groups were 80 g (20-140) and 0.3 cm (-0.0 to 0.6). Compared with controls, babies in the AZI-SP group had a relative risk of 0.61 (0.40-0.93) for low birthweight, 0.60 (0.44-0.81) for stunting and 0.48 (0.29-0.79) for underweight at four weeks of age. Corresponding differences were similar but smaller between the monthly SP and control groups.. An IPTp regimen with monthly SP given to all pregnant women is likely to increase mean birthweight and length at four weeks of age in malaria holoendemic areas. Adding azithromycin to the regimen appears to offer further benefits in reducing foetal and neonatal growth faltering.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Antimalarials; Azithromycin; Birth Weight; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Fetal Development; Humans; Infant, Newborn; Malaria, Falciparum; Malawi; Pregnancy; Pregnancy Complications, Parasitic; Pyrimethamine; Reproductive Tract Infections; Sulfadoxine; Young Adult

The purpose of this study was to assess presumptive sexually transmitted disease treatment on pregnancy outcome and HIV transmission.. In a randomized trial in Rakai District, Uganda, 2070 pregnant women received presumptive sexually transmitted disease treatment 1 time during pregnancy at varying gestations, and 1963 control mothers received iron/folate and referral for syphilis. Maternal-infant sexually transmitted disease/HIV and infant outcomes were assessed. Intent-to-treat analyses estimated adjusted rate ratios and 95% confidence intervals.. Sexually transmitted diseases were reduced: Trichomonas vaginalis (rate ratio, 0.28; 95% CI, 0.18%-0.49%), bacterial vaginosis (rate ratio, 0.78; 95% CI, 0.69-0.87), Neisseria gonorrhoeae /Chlamydia trachomatis (rate ratio, 0.43; 95% CI, 0.27-0.68), and infant ophthalmia (rate ratio, 0.37; 95% CI, 0.20-0.70). There were reduced rates of neonatal death (rate ratio, 0.83; 95% CI, 0.71-0.97), low birth weight (rate ratio, 0.68; 95% CI, 0.53-0.86), and preterm delivery (rate ratio, 0.77; 95% CI, 0.56-1.05); but there were no effects on maternal HIV acquisition or perinatal HIV transmission.. Reductions of maternal sexually transmitted disease improved pregnancy outcome but not maternal HIV acquisition or perinatal HIV transmission.

Topics: Azithromycin; Birth Weight; Cefixime; Drug Therapy, Combination; Endophthalmitis; Female; Folic Acid; HIV Infections; Humans; Infant; Infant Mortality; Infant, Newborn; Infant, Newborn, Diseases; Infant, Premature; Iron; Metronidazole; Obstetric Labor, Premature; Pregnancy; Pregnancy Complications, Infectious; Sexually Transmitted Diseases; Uganda

Prophylactic antibiotics to prolong latency and reduce the risk of neonatal and maternal infections are used for preterm premature rupture of membranes. This study compared outcomes between two macrolides: roxithromycin given twice a day for a week and azithromycin, given as a single dose, which is more convenient.. Two local protocols were retrospectively compared: roxithromycin and ampicillin from July 2005 to May 2016, and azithromycin and ampicillin from May 2016 to May 2018. Inclusion criteria were singleton pregnancy, at 24-34 weeks of gestation upon admission with preterm premature rupture of membranes. Primary outcome was length of the latency period, defined as time from first antibiotic dose to 34 + 0 weeks, or spontaneous or indicated delivery prior to 34 + 0 weeks. Secondary outcomes were rates of chorioamnionitis, delivery mode, birth weight and Apgar scores.. A total of 207 women met inclusion criteria, of whom, 173 received penicillin and roxithromycin and 34 received penicillin and azithromycin. Baseline characteristics were similar between groups. The latent period was longer in the azithromycin group than in the roxithromycin group (14.09 ± 14.2 days and 7.87 ± 10.2 days, respectively, P = 0.003). Rates of chorioamnionitis, cesarean deliveries, Apgar scores and birth weights were similar between the groups.. Azithromycin compared to roxithromycin results in a longer latency period in the setting of preterm premature rupture of membranes at 24-34 weeks of gestation. Given its more convenient regimen and our results, it seems justified to use azithromycin as the first-line treatment for patients with preterm premature rupture of membranes.

Topics: Adult; Ampicillin; Anti-Bacterial Agents; Antibiotic Prophylaxis; Apgar Score; Azithromycin; Birth Weight; Cesarean Section; Chorioamnionitis; Comparative Effectiveness Research; Drug Administration Schedule; Female; Fetal Membranes, Premature Rupture; Humans; Infant, Newborn; Obstetric Labor Complications; Pregnancy; Pregnancy Outcome; Retrospective Studies; Roxithromycin; Treatment Outcome

In Papua New Guinea, intermittent preventive treatment with sulphadoxine-pyrimethamine and azithromycin (SPAZ-IPTp) increased birthweight despite limited impact on malaria and sexually transmitted infections. To explore possible nutrition-related mechanisms, we evaluated associations between gestational weight gain (GWG), enrolment body mass index (BMI) and mid-upper arm circumference (MUAC), and birthweight. We investigated whether the increase in birthweight associated with SPAZ-IPTp may partly be driven by a treatment effect on GWG. The mean GWG rate was 393 g/week (SD 250; n = 948). A 100 g/week increase in GWG was associated with a 14 g (95% CI 2.6, 25.4) increase in birthweight (P = 0.016). Enrolment BMI and MUAC also positively correlated with birthweight. SPAZ-IPTp was associated with increased GWG [58 g/week (26, 900), P < 0.001, n = 948] and with increased birthweight [48 g, 95% CI (8, 880), P = 0.019] when all eligible women were considered (n = 1947). Inclusion of GWG reduced the birthweight coefficient associated with SPAZ-IPTp by 18% from 44 to 36 g (n = 948), although SPAZ-IPTp was not significantly associated with birthweight among women for whom GWG data were available (P = 0.13, n = 948). One month post-partum, fewer women who had received SPAZ-IPTp had a low post-partum BMI (<18.5 kg m(-2) ) [adjusted risk ratio: 0.55 (95% CI 0.36, 0.82), P = 0.004] and their babies had a reduced risk of wasting [risk ratio 0.39 (95% CI 0.21, 0.72), P = 0.003]. SPAZ-IPTp increased GWG, which could explain its impact on birthweight and maternal post-partum BMI. Future trials of SPAZ-IPTp must incorporate detailed anthropometric evaluations to investigate mechanisms of effects on maternal and child health.

Topics: Adolescent; Antimalarials; Azithromycin; Birth Weight; Body Mass Index; Drug Combinations; Female; Follow-Up Studies; Humans; Infant, Low Birth Weight; Linear Models; Malnutrition; Maternal Exposure; Multivariate Analysis; Nutritional Status; Papua New Guinea; Pregnancy; Pyrimethamine; Risk Factors; Socioeconomic Factors; Sulfadoxine; Weight Gain