Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Use of Progesterone to Reduce Preterm Birth
Brief Summary: Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for another early delivery). There are other studies that show that this technique of giving a weekly shot of progesterone does not prevent preterm birth. In addition, There are other groups of patients who are at very high risk for preterm birth which have not been studied. They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal gestation (twins, triplets, etc.); 3.) Women with preterm (\<34 weeks) rupture of the membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes who have been tocolyzed (have their labor stopped and are getting ready to go home). We purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in the first group who are at risk for preterm delivery due to an early birth in a previous pregnancy as well as the other four groups listed. If progesterone given weekly is successful at preventing early delivery as compared to the placebo group then great benefit for these women as well as future pregnancies would be accrued.


Options:
A: Inclusion Criteria:

1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2.5 cm or less measured by transvaginal ultrasound with the current pregnancy. "Spontaneous preterm delivery" is a delivery (\<35 weeks), either vaginal or cesarean, that is initiated by either preterm PROM followed by contractions or preterm labor initiated with in-tact membranes. A previous preterm delivery secondary to an incompetent cervix where a cerclage is considered for this pregnancy is not considered a preterm delivery (please see Exclusion Criteria No. 10). Subjects enrolled based on a history of preterm delivery may have had a pregnancy loss (or losses) at \<20 0/7 weeks gestational age between the preceding preterm delivery and the current pregnancy.
2. The female subject is between 18 and 45 years of age at the time of screening.
3. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks.
4. The subject speaks either English or a common local language.
5. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
6. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.

Exclusion Criteria:

1. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
2. The subject has been treated with a progestogen within the previous 4 weeks.
3. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
4. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
5. The subject has liver dysfunction or disease.
6. The subject has known or suspected malignancy of the breast or genital organs.
7. The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study.
8. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
9. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
10. The subject has a multifetal gestation.
11. The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy.
12. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.
13. The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment.
14. The subject is HIV positive with a CD4 count of _\<350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus.
15. The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions.
16. The subject's qualifying preterm delivery was an indicated delivery without preterm labor (i.e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions).
B: Inclusion Criteria:

* Twin pregnancy
* Informed consent
* 18-23 weeks' gestation
* Participants must be fluent in the language spoken in the respective centres

Exclusion Criteria:

* Age \< 18 years
* Known allergy to progesterone or peanuts
* Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
* Rupture of membranes at the time of inclusion
* Monoamniotic twins
* Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
* Multiple pregnancies reduced to twin pregnancies
* Known significant structural or chromosomal fetal abnormality
* Chorionicity not assessed before 15 weeks
* Known or suspected malignancy in genitals or breasts
* Known liver disease
C: Inclusion Criteria:

* Pregnancy 20 - 34 weeks; cervical dilation \<4 cm; risk for preterm birth; multifetal gestation; diagnosis of preterm labor during the current pregnancy effectively tocolyzed); preterm rupture of the fetal membranes (24 - 34 weeks); willing and able to sign Informed Consent Form

Exclusion Criteria:

* Failure to meet inclusion criteria as noted above; contraindication to pregnancy continuation; severe medical diseases such as sickle cell disease with crises, diabetes mellitus (F/R/H), severe preeclampsia etc., (physician judgment; severe fetal/obstetric criteria such as intrauterine growth restriction (\<5th percentile, placental abruption,placental previa, etc., (physician judgment); non reassuring fetal assessment; allergy to progesterone compounds; refusal to participate
D: Inclusion Criteria:

* All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (\<15 mm).

Exclusion Criteria:

* Women with major fetal abnormalities,
* Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.

Answer: C