The APPLe Study: A Randomized, Community-Based, Placebo-Controlled Trial of Azithromycin for the Prevention of Preterm Birth, with Meta-Analysis

Broek, Nynke van den; White, Sarah; Goodall, M. C.; Ntonya, C.; Kayira, Edith; Kafulafula, George; Neilson, James P

doi:10.1371/journal.pmed.1000191

Cited by 69 publications

(51 citation statements)

References 42 publications

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“…A meta-analysis of these trials has failed to show an improvement on neonatal outcomes. 33 Our study differed from these previous studies because it was the first to administer azithromycin to women in labor. The primary outcome of the trial was bacterial carriage 16 and the analysis of clinical outcomes, which we report in this article, was conducted post hoc.…”

Section: Discussionmentioning

confidence: 81%

Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial

et al. 2017

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Section: Discussionmentioning

confidence: 81%

Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial

et al. 2017

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“…21 The dose and timing of azithromycin was the same as in our trial, but the APPLe intervention combined azithromycin to preventive malaria treatment with two doses of SP, whereas in our trial SP was administered monthly, either with or without azithromycin. Furthermore, the participants in the APPLe trial were more often primigravida, and the prevalenceof syphilis at enrollment and peripheral malaria parasitemia were higher at enrollment and at the time of the second azithromycin trial.…”

Section: Discussionmentioning

confidence: 99%

“…A trial in Uganda reported an apparently reduced incidence of preterm delivery and LBW among participants treated with antibiotics, whereas no impact on the incidence of preterm delivery or mean duration of pregnancy was found in a trial in Malawi. 13,21 No trials in sub-Saharan Africa have addressed the impact on preterm deliveries of IPT with a combination of monthly antimalarial drugs and antibiotics against RTIs.…”

Section: Introductionmentioning

confidence: 99%

Effect of Repeated Treatment of Pregnant Women with Sulfadoxine-Pyrimethamine and Azithromycin on Preterm Delivery in Malawi: A Randomized Controlled Trial

Luntamo

Kulmala²,

Mbewe³

et al. 2010

The American Society of Tropical Medicine and Hygiene

127

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Abstract. Preterm delivery, which is associated with infections during pregnancy, is common in sub-Saharan Africa. We enrolled 1,320 pregnant women into a randomized, controlled trial in Malawi to study whether preterm delivery and low birth weight (LBW) incidence can be reduced by intermittent preventive treatment of maternal malaria and reproductive tract infections. The participants received either sulfadoxine-pyrimethamine (SP) twice (controls), monthly SP, or monthly SP and two doses of azithromycin (AZI-SP). The incidence of preterm delivery was 17.9% in controls, 15.4% in the monthly SP group ( P = 0.32), and 11.8% in AZI-SP group (risk ratio = 0.66, P = 0.01). Compared with controls, those in AZI-SP group had a risk ratio of 0.61 ( P = 0.02) for LBW. Incidence of serious adverse events was low in all groups. In conclusion, the incidence of preterm delivery and LBW can in some conditions be reduced by treating pregnant women with monthly SP and two azithromycin doses.

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“…A study conducted by Broek et al in 2009 in Malawi, where the incidence of preterm labor was more prevalent in multigravida women was 57.2% compared with primigravida of 36.3% . 9 In another study, it was said that nulliparous women had lower gestational age compared with multiparous women (32.2 ± 0.2 versus 33.0 ± 0.1 weeks). This can be attributed to the fact that in nullipara women, had higher incidence of oligohydramnios, incompetent cervix, hypertension in pregnancy, and eclampsia.…”

Section: Characteristics Of Preterm Labor Based On Gravidamentioning

confidence: 95%

Characteristics of Preterm Birth Cases at Sanglah Hospital Denpasar (Period from 1 January to 31 December 2016)

2017

IJSR

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Background: Preterm labor is a major cause of death and an important cause of congenital disabilities. According to WHO, preterm delivery is a labor that occurs between 20 weeks' gestation to less than 37 weeks, calculated from the first day of the last menstrual on a 28-day cycle. This study aims to determine the characteristics of pregnancy and preterm delivery at Sanglah Hospital during the year 2016. Methods: This is a retrospective research using descriptive methods; data were taken from Sanglah Hospital medical record. All cases of preterm labor in Sanglah Denpasar Hospital delivery room from 1 January to 31 December 2016 were used, information starting from the initial diagnosis at admission and the patient's medical record number were also recorded. Data were then processed with tabulation method in accordance with the characteristics of preterm labor cases. The results data were then analyzed descriptively using SPSS 16 software. Results & Discussions: The results showed that within 1 year from 1 January to 31 December 2016, from all deliveries, there was 195 (18.6%) preterm birth cases in midwifery Sanglah Denpasar Hospital. Preterm labor was most common at the age of 20-35 years old (77.9%), at the age of pregnancy 32 to <37 weeks (67.6%). Preterm birth occurs highest in mothers with primigravida (42.5%). This research also found that in 22 cases with preterm birth, previously had experienced preterm labor, where 19 cases (9.7%) had 1 preterm delivery, and 3 cases (1.5% ) had a history of 2 previous preterm deliveries. Based on medical history experienced by a mother with preterm delivery at Sanglah Hospital Denpasar, 49 (25.1%) had hypertension in pregnancy. Babies born preterm in Sanglah Denpasar Hospital period 1 January to 31 December 2016 most had a birth weight between 1500 to <2500 grams, where 150 babies (70%) was born with vigorous counts. There were 167 infants (78%) who were preterm born in Sanglah Denpasar Hospital from January 1 to December 31 2016 treated with joint care, and the remaining 29 (13.5%) were admitted to the Neonatal Intensive Care Unit (NICU). Conclusions: This research is a preliminary study that can be used as reference data about the characteristics of preterm labor in obstetrics and gynecology Sanglah Hospital Denpasar Periode January 1 to December 31, 2016. Given the importance of these data, this study may be used as basic data to do a continuous research, to find out all other characteristics. Also to find the occurrence of preterm labor and its complications, so in the near future can be used as a consideration for the management of preterm labor, also reduce and anticipate complications that could happen.

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The APPLe Study: A Randomized, Community-Based, Placebo-Controlled Trial of Azithromycin for the Prevention of Preterm Birth, with Meta-Analysis

Abstract: In a randomized trial in Malawi of azithromycin versus placebo in over 2,000 pregnant women, Jim Neilson and colleagues show no benefit of azithromycin for a number of outcomes including preterm birth and prenatal death.

Cited by 69 publications

References 42 publications

Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial

Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial

Effect of Repeated Treatment of Pregnant Women with Sulfadoxine-Pyrimethamine and Azithromycin on Preterm Delivery in Malawi: A Randomized Controlled Trial

Characteristics of Preterm Birth Cases at Sanglah Hospital Denpasar (Period from 1 January to 31 December 2016)

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