Trial Outcomes & Findings for Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (NCT NCT00706264)

NCT ID: NCT00706264

Last Updated: 2021-03-17

Results Overview

Number of spontaneous preterm births before 34 weeks occurred in each group.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 385 participants
• Primary outcome timeframe: Between 24 and 34 weeks
• Results posted on: 2021-03-17

Participant Flow

You are right that our fi rst planned sample size was 2780 patients. However, after the first interim analysis, and in accordance with the advice of our Data Monitoring Committee, the protocol was amended to reach the new and fi nal sample size.

Participant milestones

Measure	Expectant Management Expectant management: Current conventional management.	Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks Placement of arabin pessary since 23 weeks until 37 weeks Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix.
Overall Study STARTED	193	192
Overall Study COMPLETED	190	190
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

Baseline characteristics by cohort

Measure	Expectant Management n=190 Participants Both groups were seen by the clinical team of the trial at each centre every month until delivery. Transabdominal ultrasonography was done for fetal biometries and wellbeing, clinical questionnaire was administered for confi rmation of correct device placement in the pessary group (fi gure 2), vaginal swab was taken for study of bacteriological infection, and transvaginal ultra sonography was done to measure cervical length (fi gure 3)	Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks n=190 Participants The pessary was removed during the 37th week of gestation. Indications for pessary removal before this time were active vaginal bleeding, risk of preterm labour with persistent contractions despite tocolysis, or severe patient discomfort.	Total n=380 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=5 Participants	190 Participants n=7 Participants	380 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.6 years STANDARD_DEVIATION 5.4 • n=5 Participants	30.3 years STANDARD_DEVIATION 5.1 • n=7 Participants	30.1 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	190 Participants n=7 Participants	380 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	58 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants n=5 Participants	132 Participants n=7 Participants	266 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	190 participants n=5 Participants	190 participants n=7 Participants	380 participants n=5 Participants

PRIMARY outcome

Timeframe: Between 24 and 34 weeks

Number of spontaneous preterm births before 34 weeks occurred in each group.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Spontaneous Delivery Before 34 Completed Weeks	51 Participants	12 Participants

SECONDARY outcome

Timeframe: Time of delivery

Number of newborns whose birthweight is less than 1500 grams

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Birthweight Less Than 1500 g	26 Participants	9 Participants

SECONDARY outcome

Timeframe: Time of delivery

Number of newborns whose birthweight is less than 2500 grams

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Birthweight Less Than 2500 g	56 Participants	17 Participants

SECONDARY outcome

Timeframe: Pregnancy

The number of fetal deaths in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Intrauterine Fetal Demise	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal deaths in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Neonatal Death	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Intraventricular Haemorrhage	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Respiratory Distress Syndrome	23 Participants	5 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Retinopathy of Prematurity	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Necrotising Enterocolitis	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Treatment for Sepsis	12 Participants	3 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Composite Adverse Outcomes	30 Participants	5 Participants

SECONDARY outcome

Timeframe: Between 24 and 28 weeks

Number of preterm births before 28 weeks occurred in each group.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Spontaneous Delivery Before 28 Completed Weeks	16 Participants	4 Participants

SECONDARY outcome

Timeframe: Between 24 and 34 weeks

Number of all preterm births before 34 weeks occurred in each group.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Any Delivery Before 34 Completed Weeks	53 Participants	14 Participants

SECONDARY outcome

Timeframe: Between 24 and 37 weeks

Number of preterm births before 37 weeks occurred in each group.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Spontaneous Delivery Before 37 Completed Weeks	113 Participants	41 Participants

SECONDARY outcome

Timeframe: At time of birth

Number of weeks of gestation completed by time of delivery

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Gestational Age at Delivery	34.9 weeks Standard Deviation 4.0	37.7 weeks Standard Deviation 2.0

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants required use of tocolytic medication

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Use of Tocolysis	101 Participants	64 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants that received betamethasone to reduce morbidity of expected preterm delivery

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Use of Antenatal Steroids	121 Participants	80 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Chorioamnionitis	6 Participants	5 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants who experienced bleeding from lower genital tract during antepartum period

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Vaginal Bleeding	9 Participants	7 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Preterm Premature Rupture of Membranes	17 Participants	3 Participants

SECONDARY outcome

Timeframe: At time of delivery

Number of participants that underwent cesarean delivery

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Cesarean Delivery	40 Participants	41 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants who experienced an increased vaginal discharge.

Outcome measures

Measure	No Intervention: No Pessary n=190 Participants No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Vaginal Discharge	87 Participants	190 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).

Outcome measures

Measure	No Intervention: No Pessary No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Pessary Repositioning Without Removal	0 Participants	27 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of pregnancy, up to nine months

Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).

Outcome measures

Measure	No Intervention: No Pessary No pessary will be used. Subjects will receive standard obstetrical care and management.	Experimental: Pessary n=190 Participants Use of Arabin pessary. Pessary placed around the cervix between 20 and 23 weeks gestation, and will be removed during the 37th week of pregnancy.
Pessary Withdrawal	0 Participants	1 Participants

Adverse Events

Expectant Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria M Goya

Hospital Vall d'Hebron

Phone: 934893085

Email: maria.goya@vhir.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place