Cervical Insufficiency
Conditions
Keywords
cervical insufficiency
Brief summary
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage. The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.
Interventions
DRUGIndomethacin and antibiotics (cefazolin or clindamycin)
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* GA 16+0 to 23+6 weeks * Singleton gestation * Presence of cervical dilation as diagnosed on digital examination * Intact membranes
Exclusion criteria
* Age \<18 years * Allergy to NSAIDs * Renal disease * Allergy to penicillins AND clindamycin * Currently on antibiotics or indomethacin for any reason * HIV positive * Pregnancies complicated by fetal congenital anomalies * Preterm premature rupture of membranes * Fever of 100.4 degrees Fahrenheit or higher * Any patient having received a therapeutic cerclage during the current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | 24 weeks | Median gestational latency achieved Between Cerclage Placement and Time of Delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Latency of More Than 28 Days | 28 days postpartum | The frequency of achieving a gestational latency of more than 28 days |
| Gestational Age at Delivery | 24 weeks | Median gestational age at delivery |
| Neonatal Morbidity and Mortality | 1 year | Days spent in the neonatal intensive care unit |
| Birthweight | 24 weeks | Median birthweight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control emergent cerclage with no peri-operative antibiotics or indomethacin | 24 |
| Indomethacin and Antibiotics perioperative antibiotics and indomethacin
Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Control | Indomethacin and Antibiotics | Total |
|---|---|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 4.9 | 31.9 years STANDARD_DEVIATION 6.5 | 30.3 years STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | 80 days |
| Indomethacin and Antibiotics | Gestational Latency Achieved Between Cerclage Placement and Time of Delivery | 97 days |
Comparison: Kaplan Meier survival analysisp-value: 0.018Log Rank
Secondary
Birthweight
Median birthweight
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Birthweight | 2488 grams |
| Indomethacin and Antibiotics | Birthweight | 2850 grams |
Secondary
Gestational Age at Delivery
Median gestational age at delivery
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Gestational Age at Delivery | 31.1 weeks |
| Indomethacin and Antibiotics | Gestational Age at Delivery | 34.8 weeks |
p-value: 0.393Kruskal-Wallis
Secondary
Gestational Latency of More Than 28 Days
The frequency of achieving a gestational latency of more than 28 days
Time frame: 28 days postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Gestational Latency of More Than 28 Days | 62.5 percentage of participants |
| Indomethacin and Antibiotics | Gestational Latency of More Than 28 Days | 92.3 percentage of participants |
95% CI: [1.06, 2.05]
Secondary
Neonatal Morbidity and Mortality
Days spent in the neonatal intensive care unit
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Neonatal Morbidity and Mortality | 95 days |
| Indomethacin and Antibiotics | Neonatal Morbidity and Mortality | 43 days |