Preterm Birth
Conditions
Keywords
Preterm birth, Short cervix, Cervical Pessaries, Progesterone
Brief summary
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.
Detailed description
Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors: 1. preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation; 2. premature rupture of membranes prior to 35 (34 and 6 days) weeks of gestation. After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks. The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.
Interventions
DRUGProgesterone Cervical Pessary 6.3 g
Progesterone Cervical Pessary low dose
Progesterone 200 mg vaginal capsules daily
DRUGProgesterone Cervical Pessary 7.7 g
Progesterone Cervical Pessary high dose
Sponsors
Laboratorios Andromaco S.A.
Grünenthal GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24 weeks of gestation, without any previous factors. * Women with a single pregnancy with 10 mm or more cervical length between 16 and 24 weeks of gestation, and pre-existing risk factors risk factors for preterm birth: * Previous preterm birth before week 35. * Previous rupture of membranes before week 35
Exclusion criteria
* Pregnancies with: * Major fetal abnormalities, such as lethal malformations or malformations requiring pre- or post-natal surgery; and fetal death before inclusion into the study. * History of rupture of membranes or prophylactic cerclage before study entry. * Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas). * Unconscious, severely ill or mentally disabled patients, or under 16 years of age. * Patients for whom use of progesterone is contraindicated. * Patients with history of thrombosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | Up to 36 weeks of gestational age | To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery. For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period. The number of participants not giving birth before 32 weeks and 34 weeks are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Premature Rupture of Membranes | Up to 36 weeks of gestational age | A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician. |
| Anatomical Feature: Length of the Uterine Cervix | Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. | During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. |
| Anatomical Feature: Position of the Uterine Cervix | Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. | During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus. |
| Acceptability and Tolerance of Use of the Cerclage Pessary | Up to 36 weeks of gestational age | A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected. |
| Number of Adverse Events Related With the Use of Treatment | Up to 36 weeks of gestational age | The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness. |
Countries
Chile
Participant flow
Recruitment details
The trial started on 02 Sep 2013 with the enrollment of the first participant and was completed on 13 Mar 2017 when the last participant completed the last follow-up examination according to the protocol. 271 participants signed and informed consent. All 271 were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Progesterone Cervical Pessary (6.3 g) Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal. | 91 |
| Progesterone Cervical Pessary (7.7 g) Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal. | 90 |
| Progesterone 200 mg Vaginal Capsules Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant. | 90 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 3 |
| Overall Study | Protocol Violation | 4 | 5 | 12 |
Baseline characteristics
| Characteristic | Progesterone Cervical Pessary (6.3 g) | Progesterone Cervical Pessary (7.7 g) | Progesterone 200 mg Vaginal Capsules | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 91 Participants | 90 Participants | 90 Participants | 271 Participants |
| Age, Continuous | 27.57 years STANDARD_DEVIATION 6.5 | 27.60 years STANDARD_DEVIATION 6.2 | 28.18 years STANDARD_DEVIATION 5.16 | 27.78 years STANDARD_DEVIATION 5.97 |
| Body Mass Index (BMI) | 27.03 kilogram per square meter STANDARD_DEVIATION 4.92 | 28.61 kilogram per square meter STANDARD_DEVIATION 5.45 | 28.23 kilogram per square meter STANDARD_DEVIATION 4.56 | 27.95 kilogram per square meter STANDARD_DEVIATION 5.01 |
| Height | 1.57 meter STANDARD_DEVIATION 0.06 | 1.58 meter STANDARD_DEVIATION 0.06 | 1.58 meter STANDARD_DEVIATION 0.05 | 1.58 meter STANDARD_DEVIATION 0.05 |
| Medical History - Prior Pregnancy Premature Rupture of Membrane | 24 Participants | 20 Participants | 17 Participants | 61 Participants |
| Medical History - Prior Preterm Birth | 55 Participants | 55 Participants | 50 Participants | 160 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 91 Participants | 90 Participants | 90 Participants | 271 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Chile | 91 participants | 90 participants | 90 participants | 271 participants |
| Sex: Female, Male Female | 91 Participants | 90 Participants | 90 Participants | 271 Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants |
| Weight | 66.65 kilogram STANDARD_DEVIATION 13.36 | 71.26 kilogram STANDARD_DEVIATION 14.06 | 70.62 kilogram STANDARD_DEVIATION 12.73 | 69.50 kilogram STANDARD_DEVIATION 13.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 77 / 91 | 73 / 90 | 65 / 90 |
| serious Total, serious adverse events | 36 / 91 | 35 / 90 | 33 / 90 |
Outcome results
Primary
Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation
To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery. For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period. The number of participants not giving birth before 32 weeks and 34 weeks are reported.
Time frame: Up to 36 weeks of gestational age
Population: 271 participants comprised the Intention-to-treat analysis (ITT) population at baseline, 268 participants at gestation week 32, and 262 participants at gestation week 34.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Progesterone Cervical Pessary (6.3 g) | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 32 weeks | 73 Participants |
| Progesterone Cervical Pessary (6.3 g) | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 34 weeks | 66 Participants |
| Progesterone Cervical Pessary (7.7 g) | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 32 weeks | 71 Participants |
| Progesterone Cervical Pessary (7.7 g) | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 34 weeks | 64 Participants |
| Progesterone 200 mg Vaginal Capsules | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 32 weeks | 67 Participants |
| Progesterone 200 mg Vaginal Capsules | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | No birth before 34 weeks | 61 Participants |
Secondary
Acceptability and Tolerance of Use of the Cerclage Pessary
A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected.
Time frame: Up to 36 weeks of gestational age
Population: No participants were analyzed
Secondary
Anatomical Feature: Length of the Uterine Cervix
During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed.
Time frame: Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.
Population: Intention-to-treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Baseline Visit | 28.69 millimeter | Standard Deviation 9.06 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 2 | 28.51 millimeter | Standard Deviation 8.3 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 3 | 27.54 millimeter | Standard Deviation 7.27 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 4 | 27.82 millimeter | Standard Deviation 7.12 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 5 | 27.53 millimeter | Standard Deviation 7.4 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 6 | 27.42 millimeter | Standard Deviation 7.62 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 7 | 30.43 millimeter | Standard Deviation 9.39 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Length of the Uterine Cervix | Final Visit | 22.98 millimeter | Standard Deviation 8.06 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 3 | 29.06 millimeter | Standard Deviation 7.65 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 7 | 27.95 millimeter | Standard Deviation 8.85 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 4 | 27.60 millimeter | Standard Deviation 7.91 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 5 | 26.55 millimeter | Standard Deviation 7.81 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 6 | 27.28 millimeter | Standard Deviation 9.36 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Baseline Visit | 29.62 millimeter | Standard Deviation 8.66 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Visit 2 | 30.34 millimeter | Standard Deviation 7.63 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Length of the Uterine Cervix | Final Visit | 25.07 millimeter | Standard Deviation 7.49 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 3 | 30.76 millimeter | Standard Deviation 8.28 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 2 | 29.29 millimeter | Standard Deviation 10.37 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Baseline Visit | 28.44 millimeter | Standard Deviation 8.55 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 4 | 29.37 millimeter | Standard Deviation 8.16 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 7 | 28.83 millimeter | Standard Deviation 8 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 6 | 27.49 millimeter | Standard Deviation 8.32 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Visit 5 | 28.63 millimeter | Standard Deviation 10.16 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Length of the Uterine Cervix | Final Visit | 23.64 millimeter | Standard Deviation 9.26 |
Secondary
Anatomical Feature: Position of the Uterine Cervix
During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus.
Time frame: Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.
Population: Intention-to-treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Baseline Visit | 114.54 degrees | Standard Deviation 22.58 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 2 | 111.47 degrees | Standard Deviation 23.33 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 3 | 110.81 degrees | Standard Deviation 17.78 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 4 | 105.58 degrees | Standard Deviation 21.35 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 5 | 108.99 degrees | Standard Deviation 21.97 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 6 | 112.96 degrees | Standard Deviation 17.41 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 7 | 118.93 degrees | Standard Deviation 14.1 |
| Progesterone Cervical Pessary (6.3 g) | Anatomical Feature: Position of the Uterine Cervix | Final Visit | 104.30 degrees | Standard Deviation 23.98 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 3 | 109.83 degrees | Standard Deviation 25.65 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 7 | 110.51 degrees | Standard Deviation 20.94 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 4 | 117.61 degrees | Standard Deviation 18.63 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 5 | 115.50 degrees | Standard Deviation 19.15 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 6 | 114.50 degrees | Standard Deviation 21.61 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Baseline Visit | 112.59 degrees | Standard Deviation 22.48 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Visit 2 | 115.02 degrees | Standard Deviation 19.56 |
| Progesterone Cervical Pessary (7.7 g) | Anatomical Feature: Position of the Uterine Cervix | Final Visit | 113.42 degrees | Standard Deviation 24.76 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 3 | 115.36 degrees | Standard Deviation 24.93 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 2 | 109.74 degrees | Standard Deviation 23.56 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Baseline Visit | 112.85 degrees | Standard Deviation 20.03 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 4 | 113.29 degrees | Standard Deviation 26.2 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 7 | 124.37 degrees | Standard Deviation 13.32 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 6 | 121.65 degrees | Standard Deviation 15.89 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Visit 5 | 113.26 degrees | Standard Deviation 15.21 |
| Progesterone 200 mg Vaginal Capsules | Anatomical Feature: Position of the Uterine Cervix | Final Visit | 115.44 degrees | Standard Deviation 16.14 |
Secondary
Number of Adverse Events Related With the Use of Treatment
The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness.
Time frame: Up to 36 weeks of gestational age
Population: Intention-to-treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Progesterone Cervical Pessary (6.3 g) | Number of Adverse Events Related With the Use of Treatment | AE related to use of treatment | 31 events |
| Progesterone Cervical Pessary (6.3 g) | Number of Adverse Events Related With the Use of Treatment | Unexpected serious adverse events | 1 events |
| Progesterone Cervical Pessary (7.7 g) | Number of Adverse Events Related With the Use of Treatment | AE related to use of treatment | 22 events |
| Progesterone Cervical Pessary (7.7 g) | Number of Adverse Events Related With the Use of Treatment | Unexpected serious adverse events | 2 events |
| Progesterone 200 mg Vaginal Capsules | Number of Adverse Events Related With the Use of Treatment | AE related to use of treatment | 2 events |
| Progesterone 200 mg Vaginal Capsules | Number of Adverse Events Related With the Use of Treatment | Unexpected serious adverse events | 0 events |
Secondary
Number of Participants With Premature Rupture of Membranes
A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician.
Time frame: Up to 36 weeks of gestational age
Population: Intention-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Progesterone Cervical Pessary (6.3 g) | Number of Participants With Premature Rupture of Membranes | 1 Participants |
| Progesterone Cervical Pessary (7.7 g) | Number of Participants With Premature Rupture of Membranes | 4 Participants |
| Progesterone 200 mg Vaginal Capsules | Number of Participants With Premature Rupture of Membranes | 3 Participants |