Preterm Birth Clinical Trial
Official title:
Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage. A Randomized Controlled Trial
In women with indicated vaginal cerclage, this study aims to assess the efficacy of antenatal prophylactic Azithromycin in preventing preterm labor.
Study procedures and interventions:
1. After approval of study protocol, pregnant women who underwent vaginal cerclage at Ain
Shams University Maternity Hospital will be enrolled into the study according to
inclusion and exclusion criteria.
2. Eligible patients will be randomized using a computer-generated sequence 1:1 either to
the Azithromycin group or to non-Azithromycin group.
Randomization: Will be done using computer generated randomization sheet using MedCalc©
version 13.
Allocation and Concealment: Will be done by use of sealed opaque envelopes that will be given
to a third party (nurse) who will assign the women to study arms. Each woman will be invited
to pull out an envelope. According to the number inside her envelope, women will be allocated
to either group 1 or group 2 according to a computer- generated random list.
3. Intervention:
1. st group (Azithromycin group): 25 women will receive 500mg Azithromycin (Zithrokan®,
Hikma, Egypt) one tablet orally twice daily for three days in 3 courses at 14wk, 24wk
and 32wk in addition to routine usual antenatal care.
2. nd group (non-Azithromycin group): 25 women will receive routine antenatal care without
antibiotic prophylaxis after cerclage.
4. Follow up: Through antenatal care at 4 weeks interval till 28 weeks gestational age then
at 2 weeks interval till delivery.
History: Routine ANC history with special comment on history of infection as (pain, bleeding,
offensive discharge).
Examination: Routine ANC examination with special comment on signs of infection (fever,
tachycardia).
Investigation: As scheduled routine labs (CBC, Urine analysis, etc) and ultrasound.
5. Data collection and recording case record form: The data will be collected in a case
record form (age, parity, body mass index (BMI), mode of the delivery, previous adverse
perinatal outcome, gestational age at time of delivery, birth weight, NICU admission, still
birth, miscarriage, antepartum hemorrhage, hospital stay, postpartum pyrexia, ICU admission,
need for blood transfusion.
To decrease risk of bias, the observer collecting the data will be blinded as regards whether
they are azithromycin group or non-azithromycin group.
Statistical analysis:
The collected data will be revised, coded, tabulated and introduced to a PC using Statistical
package for Social Science (SPSS 20.0.1 for windows; SPSS Inc, Chicago, IL, 2001).
Quantitative variables are expressed as mean and SD, or Median and Interquartile range (IQR)
according to distribution of data. Qualitative variables are expressed as frequencies and
percentages. Student t test and Mann Whitney Test will be used to compare a continuous
variable between two study groups. Chi square test will be used to examine the relationship
between Categorical variables. A P-value< 0.05 was considered statistically significant.
Ethical and Safety Consideration:
This study will be done after approval of the ethical committee of the department of
obstetrics and gynecology, faculty of medicine, Ain Shams University. Informed consent will
be taken from all participants before recruitment in the study, and after explaining the
purpose and procedures of the study. The investigator will obtain the written, signed
informed consent of each subject prior to performing any study specific procedures on the
subject. The investigator will retain the original signed informed consent form. All data
will be collected confidentially. Women with vaginal cerclage will be counseled about the
side effects associated with cerclage and Azithromycin. The study will be based on the
investigator self-funding.
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