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Azithromycin for Cerclage Prophylaxis

ConditionCervical Insufficiency
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences

About this trial

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment

Indication for transvaginal cerclage placement

Intact amniotic membranes

Disqualifiers

Evidence of active infection or chorioamnionitis at presentation

Preterm prelabor rupture of membranes (PPROM)

Multiple gestation

HIV positive status

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin Prophylaxis

    Drug

    500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.

  • Azithromycin Placebo

    Drug

    normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area

  • Cefazolin

    Drug

    All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.

  • Progesterone

    Drug

    progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cerclage and Azithromycin ProphylaxisExperimental treatment 3 interventions
Group B: Cerclage Without Azithromycin ProphylaxisActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Latency from Cerclage to Delivery

Number of days from cerclage to delivery

Time frame
Up to Week 42
2

Gestational Age at Delivery

Gestational age at delivery measured in weeks and days

Time frame
Up to Week 42

Secondary outcomes

1

Incidence of Chorioamnionitis

number of participants with chorioamnionitis

Time frame
Up to Week 42
2

Incidence of Preterm Premature Birth

Number of participants that experienced preterm premature birth

Time frame
28 weeks gestation, 34 weeks gestation, 37 weeks gestation
3

Incidence of Preterm Premature Rupture of Membranes

Number of participants that experienced preterm premature rupture of membranes

Time frame
up to 37 weeks gestation
4

Complications from Cerclage

Number participants that experienced complications from cerclage

Time frame
Up to Week 42

Other outcomes

1

Neonate Birth Weight

weight of neonate at birth

Time frame
day of delivery
2

Apgar Scores

The Apgar score is a standardized test used to rapidly assess a newborn's health immediately after birth. It is evaluated at 1 minute (to see how the baby handled delivery) and 5 minutes (to check how the baby is adapting to life outside the womb). Total score range is 0-10 with a higher score indicating newborn is adapting well to life outside the womb.

Time frame
1 minute post delivery, 5 minutes post delivery
3

Number of NICU Admissions

number of neonates admitted to NICU after delivery

Time frame
day of delivery
4

Length of NICU Admission

number of days neonates spent in NICU

Time frame
up to month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: