Azithromycin, Meconium Stained, Postpartum Endometritis
Conditions
Keywords
Azithromycin, Placebo, Postpartum Endometritis
Brief summary
Meconium stained amniotic fluid increases the risk of maternal complications (e.g., dystocia, operative delivery, and postpartum endometritis) and neonatal complications (e.g., sepsis, admission to the neonatal intensive care unit \[NICU\], and meconium aspiration syndrome). The goal of the study is to compare between Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on maternal and neonatal outcomes.
Detailed description
Meconium stained amniotic fluid, a troublesome situation both for obstetrician and pediatrician, it is associated with high rates of caesarean section, perinatal morbidity and mortality. The rate of meconium-stained amniotic fluid varies from 12 to 20%.It is higher in underdeveloped countries.Our study design would be a prospective randomized trial. Consented, eligible pregnant women presenting during the first stage of labor at or more than 37 weeks of gestation with meconium stained amniotic fluid will be randomized to receive Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12hrs on empty stomach for 3 days)(Group 1).Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, color and consistency as Azithromycin capsule for 3 days).
Interventions
DRUGAzithromycin capsule (Zithromax, Pfizer) (250 mg)
Azithromycin, a second generation macrolide, broad-spectrum antibacterial that stops bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose. .Azithromycin has been beneficial in the treatment of influenza and Middle East respiratory syndrome coronavirus (MERS-CoV) and recently has shown to be effective against severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) when used in combination with hydroxychloroquine or chloroquine.
DRUGPlacebo
A treatment that has no active properties
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be randomized to the 2 study groups according to a 2-block randomization list coded I or II at a 1:1 ratio. The randomization list will be prepared using a computer- generated random table by a statistician not otherwise involved in the study. The allocated groups will be masked in serially numbered sealed opaque envelopes that will be opened only after enrollment. Women who will be recruited give consent and open randomization envelopes in early labor, also the women will be recruited before revealing the allocation, the allocation will be blind to both the recruiter and the participant.
Intervention model description
Eligible participant will be allocated to one of two groups : Group 1 will be offered Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12 hrs on empty stomach for 3 days). Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, colour and consistency as Azithromycin capsule for 3 days). A single pharmacist will be responsible for manufacturing of placebo capsules and packing all medications into sterile boxes and labelling of them as 1 or 2.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Multigravida pregnant women with meconium stained amniotic fluid encountered either by spontaneous/artificial amniotomy during the first stage of labor in the ward provided that the gestational age at delivery is 37 weeks of gestation or more. 2. Singleton living gestation 3. Cephalic presentation 4. Adequate pelvis 5. An informed written consent for the proposed study.
Exclusion criteria
1. Primigravids 2. Women with previous cesarean section 3. Multifetal gestation 4. Intrauterine fetal death 5. Malpresentations 6. Prematurity (\<37 weeks ) 7. Abnormally invasive placenta during the current pregnancy 8. Medical disorders with pregnancy 9. Contracted pelvis 10. Evidence of maternal infection 11. Allergy to azithromycin or other macrolides that is self-reported or documented in the medical record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on occurrence of maternal fever, postpartum endometritis and skin (episiotomy/tear) infection. | within 1 week from delivery | Mothers will be followed up during her stay in the postnatal ward regarding signs of infection (fever, maternal tachycardia, offensive vaginal discharge, uterine tenderness). Postpartum follow up visit 1 week after delivery will be conducted. |
| Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on occurrence of neonatal fever , pneumonia and skin infection . | within 1 week from delivery | Neonates were followed up for incidence of neonatal pneumonia, neonatal skin infection , neonatal fever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal necessity for NICU admission and/or mechanical ventilation. | after delivery and within 1 week postartum | Incidence of NICU admission and/or mechanical ventilation in neonates born to women with MSAF |
| Occurrence of meconium aspiration | after delivery and within 1 week postpartum | Neonates will be followed up for presence or absence of meconium aspiration, APGAR score at 1 and 5 minutes, RDS. |
| 2- Side effects of drug (diarrhea, stomach cramps, vomiting, allergy and anaphylactic shock). | wwithin 1 week postpartum | Mothers follow up for incidence of side effects related to Azithromycin |
Countries
Egypt
Outcome results
None listed